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English Index EUP
English Index EUP
March 27, 2018 | Author: Priscila Lara | Category:
Particle Size Distribution
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Spectroscopy
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Tablet (Pharmacy)
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Alcohol
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Absorption Spectroscopy
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EUROPEAN PHARMACOPOEIA 8.7 INDEX To aid users the index includes a reference to the supplement in which the latest version of a text can be found. For example : Abacavir sulfate...............................................8.1‑3719 means the monograph Abacavir sulfate can be found on page 3719 of Supplement 8.1. Note that where no reference to a supplement is made, the text can be found in the principal volume. English index ..................................................................... 5851 General Notices (1) apply to all monographs and other texts Latin index .............................................................................. 5887 5849 EUROPEAN PHARMACOPOEIA 8.7 5850 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 8.7 Numerics 1. General notices........................................................... 8.2–3897 2.1.1. Droppers ........................................................................... 15 2.1.2. Comparative table of porosity of sintered-glass filters.. 15 2.1.3. Ultraviolet ray lamps for analytical purposes............... 15 2.1.4. Sieves ................................................................................. 16 2.1.5. Tubes for comparative tests ............................................ 17 2.1.6. Gas detector tubes............................................................ 17 2.1. Apparatus ............................................................................. 15 2.2.10. Viscosity - Rotating viscometer method ..................... 28 2.2.11. Distillation range ............................................... 8.5–4887 2.2.12. Boiling point....................................................... 8.5–4887 2.2.13. Determination of water by distillation ........................ 31 2.2.14. Melting point - capillary method................................. 32 2.2.15. Melting point - open capillary method ....................... 32 2.2.16. Melting point - instantaneous method............ 8.5–4888 2.2.17. Drop point ...................................................................... 32 2.2.18. Freezing point................................................................. 34 2.2.19. Amperometric titration..................................... 8.6–5091 2.2.1. Clarity and degree of opalescence of liquids ................ 21 2.2.20. Potentiometric titration .................................... 8.6–5091 2.2.21. Fluorimetry..................................................................... 35 2.2.22. Atomic emission spectrometry .................................... 35 2.2.23. Atomic absorption spectrometry ................................. 36 2.2.24. Absorption spectrophotometry, infrared.................... 38 2.2.25. Absorption spectrophotometry, ultraviolet and visible ......................................................................................... 40 2.2.26. Paper chromatography .................................................. 42 2.2.27. Thin-layer chromatography.......................................... 42 2.2.28. Gas chromatography...................................................... 43 2.2.29. Liquid chromatography..................................... 8.3–4175 2.2.2. Degree of coloration of liquids....................................... 22 2.2.30. Size-exclusion chromatography ................................... 46 2.2.31. Electrophoresis (5.8.)......................................... 8.7–5617 2.2.31. Electrophoresis ................................................... 8.7–5459 2.2.32. Loss on drying.................................................... 8.5–4888 2.2.33. Nuclear magnetic resonance spectrometry ................ 52 2.2.34. Thermal analysis (5.8.) ...................................... 8.7–5617 2.2.34. Thermal analysis ................................................ 8.6–5092 2.2.35. Osmolality....................................................................... 57 2.2.36. Potentiometric determination of ionic concentration using ion-selective electrodes ............ 8.6–5094 2.2.37. X-ray fluorescence spectrometry ................................. 59 2.2.38. Conductivity ................................................................... 59 2.2.39. Molecular mass distribution in dextrans .................... 60 2.2.3. Potentiometric determination of pH ............................. 24 2.2.40. Near-infrared spectroscopy .......................................... 62 2.2.41. Circular dichroism......................................................... 67 2.2.42. Density of solids............................................................. 68 2.2.43. Mass spectrometry......................................................... 69 2.2.44. Total organic carbon in water for pharmaceutical use............................................................................................... 71 2.2.45. Supercritical fluid chromatography ............................. 72 2.2.46. Chromatographic separation techniques .................... 72 2.2.47. Capillary electrophoresis............................................... 79 2.2.47. Capillary electrophoresis (5.8.) ........................ 8.7–5617 2.2.48. Raman spectroscopy.......................................... 8.7–5464 2.2.49. Falling ball viscometer method.................................... 85 2.2.4. Approximate pH of solutions ............................. 8.6–5091 2.2.54. Isoelectric focusing ........................................................ 85 2.2.54. Isoelectric focusing (5.8.).................................. 8.7–5617 2.2.55. Peptide mapping ............................................................ 87 2.2.55. Peptide mapping (5.8.) ...................................... 8.7–5618 2.2.56. Amino acid analysis....................................................... 90 2.2.56. Amino acid analysis (5.8.)................................. 8.7–5618 2.2.57. Inductively coupled plasma-atomic emission spectrometry ............................................................................. 97 2.2.58. Inductively coupled plasma-mass spectrometry........ 98 2.2.59. Glycan analysis of glycoproteins ................................ 100 2.2.5. Relative density................................................................. 25 2.2.60. Melting point - instrumental method ....................... 105 General Notices (1) apply to all monographs and other texts Index 2.2.61. Characterisation of crystalline solids by microcalorimetry and solution calorimetry........................ 106 2.2.64. Peptide identification by nuclear magnetic resonance spectrometry ........................................................................... 109 2.2.65. Voltametric titration .................................................... 109 2.2.66. Detection and measurement of radioactivity ........... 110 2.2.6. Refractive index................................................................ 26 2.2.7. Optical rotation ................................................................ 26 2.2.8. Viscosity ............................................................................ 27 2.2.9. Capillary viscometer method ......................................... 27 2.2. Physical and physicochemical methods ........................... 21 2.3.1. Identification reactions of ions and functional groups ...................................................................................... 119 2.3.2. Identification of fatty oils by thin-layer chromatography...................................................................... 122 2.3.3. Identification of phenothiazines by thin-layer chromatography...................................................................... 123 2.3.4. Odour .............................................................................. 123 2.3. Identification...................................................................... 119 2.4.10. Lead in sugars............................................................... 131 2.4.11. Phosphates .................................................................... 131 2.4.12. Potassium ...................................................................... 132 2.4.13. Sulfates........................................................................... 132 2.4.14. Sulfated ash ................................................................... 132 2.4.14. Sulfated ash (5.8.)............................................... 8.7–5618 2.4.15. Nickel in polyols........................................................... 132 2.4.16. Total ash ........................................................................ 132 2.4.17. Aluminium ................................................................... 132 2.4.18. Free formaldehyde ....................................................... 132 2.4.19. Alkaline impurities in fatty oils.................................. 133 2.4.1. Ammonium .................................................................... 127 2.4.20. Determination of metal catalyst or metal reagent residues .................................................................................... 133 2.4.21. Foreign oils in fatty oils by thin-layer chromatography...................................................................... 136 2.4.22. Composition of fatty acids by gas chromatography ............................................................................ 8.6–5099 2.4.23. Sterols in fatty oils........................................................ 139 2.4.24. Identification and control of residual solvents ......... 141 2.4.25. Ethylene oxide and dioxan................................ 8.4–4497 2.4.26. N,N-Dimethylaniline ................................................... 146 2.4.27. Heavy metals in herbal drugs and herbal drug preparations .................................................................. 8.2–3911 2.4.28. 2-Ethylhexanoic acid ................................................... 148 2.4.29. Composition of fatty acids in oils rich in omega-3 acids................................................................................ 8.6–5101 2.4.2. Arsenic............................................................................. 127 2.4.30. Ethylene glycol and diethylene glycol in ethoxylated substances................................................................................ 150 2.4.31. Nickel in hydrogenated vegetable oils ....................... 150 2.4.32. Total cholesterol in oils rich in omega-3 acids ......... 151 2.4.3. Calcium ........................................................................... 127 2.4.4. Chlorides......................................................................... 127 2.4.5. Fluorides.......................................................................... 128 2.4.6. Magnesium ..................................................................... 128 2.4.7. Magnesium and alkaline-earth metals ........................ 128 2.4.8. Heavy metals................................................................... 128 2.4.9. Iron .................................................................................. 131 2,4-Dichlorobenzyl alcohol ........................................... 8.1–3745 2.4. Limit tests........................................................................... 127 2.5.10. Oxygen-flask method .................................................. 158 2.5.11. Complexometric titrations.......................................... 158 2.5.12. Water : semi-micro determination ................... 8.5–4891 2.5.13. Aluminium in adsorbed vaccines .............................. 159 2.5.14. Calcium in adsorbed vaccines .................................... 159 2.5.15. Phenol in immunosera and vaccines......................... 159 2.5.16. Protein in polysaccharide vaccines ............................ 159 2.5.17. Nucleic acids in polysaccharide vaccines .................. 160 2.5.18. Phosphorus in polysaccharide vaccines .................... 160 2.5.19. O-Acetyl in polysaccharide vaccines ......................... 160 2.5.1. Acid value.............................................................. 8.6–5105 2.5.20. Hexosamines in polysaccharide vaccines.................. 160 2.5.21. Methylpentoses in polysaccharide vaccines.............. 161 5851 Index 2.5.22. Uronic acids in polysaccharide vaccines ................... 161 2.5.23. Sialic acid in polysaccharide vaccines ....................... 161 2.5.24. Carbon dioxide in gases .............................................. 161 2.5.25. Carbon monoxide in gases ......................................... 162 2.5.26. Nitrogen monoxide and nitrogen dioxide in gases.. 163 2.5.27. Oxygen in gases............................................................ 163 2.5.28. Water in gases............................................................... 163 2.5.29. Sulfur dioxide ............................................................... 164 2.5.2. Ester value....................................................................... 155 2.5.30. Oxidising substances ................................................... 164 2.5.31. Ribose in polysaccharide vaccines ............................. 164 2.5.32. Water : micro determination............................. 8.6–5105 2.5.33. Total protein ................................................................. 165 2.5.34. Acetic acid in synthetic peptides................................ 168 2.5.35. Nitrous oxide in gases ................................................. 168 2.5.36. Anisidine value............................................................. 169 2.5.37. Methyl, ethyl and isopropyl methanesulfonate in methanesulfonic acid ............................................................. 169 2.5.38. Methyl, ethyl and isopropyl methanesulfonate in active substances...................................................................... 8.7–5469 2.5.39. Methanesulfonyl chloride in methanesulfonic acid ........................................................................................... 171 2.5.3. Hydroxyl value ............................................................... 155 2.5.40. Methyl, ethyl and isopropyl toluenesulfonate in active substances...................................................................... 8.4–4501 2.5.41. Methyl, ethyl and isopropyl benzenesulfonate in active substances...................................................................... 8.7–5470 2.5.4. Iodine value .................................................................... 155 2.5.5. Peroxide value....................................................... 8.6–5105 2.5.6. Saponification value....................................................... 157 2.5.7. Unsaponifiable matter ................................................... 157 2.5.8. Determination of primary aromatic aminonitrogen.................................................................................... 157 2.5.9. Determination of nitrogen by sulfuric acid digestion .................................................................................. 157 2.5. Assays ................................................................................. 155 2.6.10. Histamine...................................................................... 184 2.6.11. Depressor substances................................................... 185 2.6.12. Microbiological examination of non-sterile products : microbial enumeration tests.................................................. 185 2.6.12. Microbiological examination of non-sterile products : microbial enumeration tests (5.8.) ............................. 8.7–5618 2.6.13. Microbiological examination of non-sterile products : test for specified micro-organisms ....................................... 189 2.6.13. Microbiological examination of non-sterile products : test for specified micro-organisms (5.8.) ................... 8.7–5618 2.6.14. Bacterial endotoxins .................................................... 194 2.6.15. Prekallikrein activator ....................................... 8.7–5475 2.6.16. Tests for extraneous agents in viral vaccines for human use ............................................................................................ 198 2.6.17. Test for anticomplementary activity of immunoglobulin..................................................................... 200 2.6.18. Test for neurovirulence of live virus vaccines .......... 202 2.6.19. Test for neurovirulence of poliomyelitis vaccine (oral)......................................................................................... 202 2.6.1. Sterility ............................................................................ 175 2.6.1. Sterility (5.8.) ........................................................ 8.7–5618 2.6.20. Anti-A and anti-B haemagglutinins .......................... 203 2.6.21. Nucleic acid amplification techniques............. 8.2–3921 2.6.22. Activated coagulation factors ..................................... 209 2.6.24. Avian viral vaccines : tests for extraneous agents in seed lots ......................................................................... 8.1–3659 2.6.25. Avian live virus vaccines : tests for extraneous agents in batches of finished product ......................................... 8.4–4505 2.6.26. Test for anti-D antibodies in human immunoglobulin.............................................................................................. 215 2.6.27. Microbiological control of cellular products ............ 216 2.6.2. Mycobacteria .................................................................. 178 2.6.30. Monocyte-activation test............................................. 217 2.6.31. Microbiological examination of herbal medicinal products for oral use and extracts used in their preparation .............................................................................. 222 5852 EUROPEAN PHARMACOPOEIA 8.7 2.6.33. Residual pertussis toxin and irreversibility of pertussis toxoid ....................................................................................... 224 2.6.7. Mycoplasmas .................................................................. 178 2.6.8. Pyrogens.......................................................................... 183 2.6.9. Abnormal toxicity .......................................................... 184 2.6. Biological tests ................................................................... 175 2.7.10. Assay of human coagulation factor VII .................... 247 2.7.11. Assay of human coagulation factor IX ...................... 248 2.7.12. Assay of heparin in coagulation factors .................... 249 2.7.13. Assay of human anti-D immunoglobulin ................. 249 2.7.14. Assay of hepatitis A vaccine ............................. 8.6–5109 2.7.15. Assay of hepatitis B vaccine (rDNA) ......................... 252 2.7.16. Assay of pertussis vaccine (acellular) ........................ 252 2.7.17. Assay of human antithrombin III .............................. 254 2.7.18. Assay of human coagulation factor II ............. 8.5–4896 2.7.19. Assay of human coagulation factor X........................ 255 2.7.1. Immunochemical methods........................................... 229 2.7.20. In vivo assay of poliomyelitis vaccine (inactivated).. 255 2.7.21. Assay of human von Willebrand factor..................... 257 2.7.22. Assay of human coagulation factor XI ............ 8.2–3930 2.7.23. Numeration of CD34/CD45+ cells in haematopoietic products ....................................................... 258 2.7.24. Flow cytometry ............................................................ 259 2.7.25. Assay of human plasmin inhibitor............................. 261 2.7.27. Flocculation value (Lf) of diphtheria and tetanus toxins and toxoids (Ramon assay) ................................................... 261 2.7.28. Colony-forming cell assay for human haematopoietic progenitor cells............................................ 262 2.7.29. Nucleated cell count and viability.............................. 263 2.7.2. Microbiological assay of antibiotics............................. 230 2.7.30. Assay of human protein C .......................................... 265 2.7.31. Assay of human protein S ........................................... 266 2.7.32. Assay of human α-1-proteinase inhibitor ................. 266 2.7.34. Assay of human C1-esterase inhibitor ............ 8.7–5479 2.7.4. Assay of human coagulation factor VIII ........... 8.2–3929 2.7.5. Assay of heparin................................................... 8.3–4187 2.7.6. Assay of diphtheria vaccine (adsorbed) ...................... 237 2.7.7. Assay of pertussis vaccine (whole cell)........................ 242 2.7.8. Assay of tetanus vaccine (adsorbed)............................ 242 2.7.9. Test for Fc function of immunoglobulin..................... 246 2.7. Biological assays ................................................................ 229 2.8.10. Solubility in alcohol of essential oils.......................... 272 2.8.11. Assay of 1,8-cineole in essential oils.......................... 272 2.8.12. Essential oils in herbal drugs...................................... 273 2.8.13. Pesticide residues ............................................... 8.6–5113 2.8.14. Tannins in herbal drugs .............................................. 275 2.8.15. Bitterness value............................................................. 276 2.8.16. Dry residue of extracts ................................................ 276 2.8.17. Loss on drying of extracts........................................... 276 2.8.18. Determination of aflatoxin B1 in herbal drugs ......... 276 2.8.1. Ash insoluble in hydrochloric acid .............................. 271 2.8.20. Herbal drugs : sampling and sample preparation .... 278 2.8.21. Test for aristolochic acids in herbal drugs ................ 279 2.8.22. Determination of ochratoxin A in herbal drugs ...... 281 2.8.23. Microscopic examination of herbal drugs ................ 282 2.8.2. Foreign matter ...................................................... 8.1–3665 2.8.3. Stomata and stomatal index.......................................... 271 2.8.4. Swelling index................................................................. 271 2.8.5. Water in essential oils .................................................... 271 2.8.6. Foreign esters in essential oils ...................................... 271 2.8.7. Fatty oils and resinified essential oils in essential oils ............................................................................................ 271 2.8.8. Odour and taste of essential oils .................................. 272 2.8.9. Residue on evaporation of essential oils ..................... 272 2.8. Methods in pharmacognosy ............................................ 271 2.9.10. Ethanol content .................................................. 8.5–4899 2.9.11. Test for methanol and 2-propanol ............................. 304 2.9.12. Sieve test........................................................................ 305 2.9.14. Specific surface area by air permeability................... 305 2.9.16. Flowability..................................................................... 307 2.9.17. Test for extractable volume of parenteral preparations ............................................................................ 308 See the information section on general monographs (cover pages) EUROPEAN PHARMACOPOEIA 8.7 2.9.17. Test for extractable volume of parenteral preparations (5.8.) ............................................................................... 8.7–5620 2.9.18. Preparations for inhalation : aerodynamic assessment of fine particles........................................................................ 309 2.9.19. Particulate contamination : sub-visible particles...... 321 2.9.19. Particulate contamination : sub-visible particles (5.8.) ............................................................................... 8.7–5620 2.9.1. Disintegration of tablets and capsules ......................... 285 2.9.1. Disintegration of tablets and capsules (5.8.)..... 8.7–5618 2.9.20. Particulate contamination : visible particles ............. 323 2.9.22. Softening time determination of lipophilic suppositories ........................................................................... 323 2.9.23. Gas pycnometric density of solids ............................. 324 2.9.25. Dissolution test for medicated chewing gums ......... 325 2.9.26. Specific surface area by gas adsorption ..................... 329 2.9.26. Specific surface area by gas adsorption (5.8.).. 8.7–5620 2.9.27. Uniformity of mass of delivered doses from multidose containers ................................................................................ 331 2.9.29. Intrinsic dissolution..................................................... 331 2.9.2. Disintegration of suppositories and pessaries ............ 287 2.9.31. Particle size analysis by laser light diffraction.......... 333 2.9.32. Porosity and pore-size distribution of solids by mercury porosimetry ............................................................. 336 2.9.33. Characterisation of crystalline and partially crystalline solids by X-ray powder diffraction (XRPD) ....................... 339 2.9.34. Bulk density and tapped density of powders.. 8.5–4901 2.9.35. Powder fineness............................................................ 346 2.9.36. Powder flow .................................................................. 346 2.9.36. Powder flow (5.8.) .............................................. 8.7–5620 2.9.37. Optical microscopy...................................................... 349 2.9.37. Optical microscopy (5.8.).................................. 8.7–5620 2.9.38. Particle-size distribution estimation by analytical sieving ...................................................................................... 351 2.9.38. Particle-size distribution estimation by analytical sieving (5.8.) .................................................................. 8.7–5620 2.9.39. Water-solid interactions : determination of sorption-desorption isotherms and of water activity......... 353 2.9.3. Dissolution test for solid dosage forms (5.8.)... 8.7–5619 2.9.3. Dissolution test for solid dosage forms ............. 8.6–5117 2.9.40. Uniformity of dosage units (5.8.)..................... 8.7–5620 2.9.40. Uniformity of dosage units ............................... 8.6–5123 2.9.41. Friability of granules and spheroids .......................... 359 2.9.42. Dissolution test for lipophilic solid dosage forms ... 361 2.9.43. Apparent dissolution ................................................... 361 2.9.44. Preparations for nebulisation : characterisation....... 363 2.9.45. Wettability of porous solids including powders....... 365 2.9.47. Demonstration of uniformity of dosage units using large sample sizes.......................................................... 8.1–3669 2.9.4. Dissolution test for transdermal patches .................... 295 2.9.5. Uniformity of mass of single-dose preparations ........ 297 2.9.6. Uniformity of content of single-dose preparations.... 298 2.9.7. Friability of uncoated tablets ........................................ 298 2.9.7. Friability of uncoated tablets (5.8.) .................... 8.7–5620 2.9.8. Resistance to crushing of tablets .................................. 299 2.9.9. Measurement of consistency by penetrometry .......... 299 2.9. Pharmaceutical technical procedures ............................. 285 3.1.10. Materials based on non-plasticised poly(vinyl chloride) for containers for non-injectable, aqueous solutions......................................................................... 8.4–4514 3.1.11. Materials based on non-plasticised poly(vinyl chloride) for containers for solid dosage forms for oral administration............................................................... 8.4–4516 3.1.1.1. Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components ................................................................... 8.4–4511 3.1.1.2. Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components ................................................................... 8.4–4513 3.1.13. Plastic additives ............................................................ 398 3.1.14. Materials based on plasticised poly(vinyl chloride) for containers for aqueous solutions for intravenous infusion .......................................................................... 8.4–4518 General Notices (1) apply to all monographs and other texts Index 3.1.15. Polyethylene terephthalate for containers for preparations not for parenteral use ...................................... 403 3.1.1. Materials for containers for human blood and blood components ............................................................................. 375 3.1.3. Polyolefins ....................................................................... 380 3.1.4. Polyethylene without additives for containers for parenteral preparations and for ophthalmic preparations.. 383 3.1.5. Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations ................... 384 3.1.6. Polypropylene for containers and closures for parenteral preparations and ophthalmic preparations ......................... 388 3.1.7. Poly(ethylene - vinyl acetate) for containers and tubing for total parenteral nutrition preparations .......................... 391 3.1.8. Silicone oil used as a lubricant ..................................... 393 3.1.9. Silicone elastomer for closures and tubing ................. 394 3.1. Materials used for the manufacture of containers ........ 375 3.2.1. Glass containers for pharmaceutical use........... 8.4–4525 3.2.2.1. Plastic containers for aqueous solutions for infusion .................................................................................... 414 3.2.2. Plastic containers and closures for pharmaceutical use................................................................................... 8.4–4530 3.2.3. Sterile plastic containers for human blood and blood components .................................................................. 415 3.2.4. Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components........... 417 3.2.5. Sterile containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution ............... 418 3.2.6. Sets for the transfusion of blood and blood components ............................................................................. 418 3.2.8. Sterile single-use plastic syringes ................................. 419 3.2.9. Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders.............................................................. 421 3.2. Containers.......................................................................... 409 3-O-Desacyl-4-monophosphoryl lipid A............................ 2000 4.1.1. Reagents ................................................................ 8.7–5483 4.1.2. Standard solutions for limit tests ....................... 8.7–5598 4.1.3. Buffer solutions .................................................... 8.7–5602 4.1. Reagents, standard solutions, buffer solutions .... 8.7–5483 4.2.1. Primary standards for volumetric solutions..... 8.7–5608 4.2.2. Volumetric solutions............................................ 8.7–5609 4.2. Volumetric analysis................................................. 8.7–5608 4-Aminobenzoic acid ............................................................. 1539 4. Reagents....................................................................... 8.7–5483 5.10. Control of impurities in substances for pharmaceutical use............................................................................................. 689 5.1.10. Guidelines for using the test for bacterial endotoxins ............................................................................... 572 5.11. Characters section in monographs ............................... 695 5.1.1. Methods of preparation of sterile products ................ 555 5.1.2. Biological indicators of sterilisation ............................ 556 5.12. Reference standards .............................................. 8.4–4681 5.1.3. Efficacy of antimicrobial preservation ........................ 557 5.14. Gene transfer medicinal products for human use ...... 705 5.1.4. Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use......... 559 5.1.4. Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use (5.8.) ............................................................................... 8.7–5621 5.1.5. Application of the F0 concept to steam sterilisation of aqueous preparations ............................................................. 560 5.15. Functionality-related characteristics of excipients...... 719 5.1.6. Alternative methods for control of microbiological quality ...................................................................................... 560 5.16. Crystallinity ..................................................................... 723 5.17.1. Recommendations on dissolution testing................. 727 5.17. Recommendations on methods for dosage forms testing....................................................................................... 727 5.1.7. Viral safety ...................................................................... 571 5.1.8. Microbiological quality of herbal medicinal products for oral use and extracts used in their preparation .................. 571 5.19. Extemporaneous preparation of radiopharmaceuticals .................................................................................. 8.7–5633 5853 ........3........................... 592 5.. 8...... specific surface area by (2.............................................................22............................................................................... 1138 Air.........2................3–4238 Agrimony............. 38 Absorption spectrophotometry...........8..............5.......................... 329 Adsorption.............................................................................. 8.............................................................. 588 5...................... 8.............. refined ............................................ 8...............................) ..... 8.................. gas............................................ 604 5............. 1502 Alginate.......................................... 8........... 8......... infrared (2............. 1482 Acidum picrinicum for homoeopathic preparations.......................................................2–3995 Albendazole....... Carrier proteins for the production of conjugated polysaccharide vaccines for human use.......5.... 8............................... 3438 Almagate .......9.................................1..............................3–4237 Agnus castus fruit dry extract ................... 1503 Alimemazine hemitartrate................................... canine................................................................18...........2..............................9..................) ............................................. Table of physical characteristics of radionuclides mentioned in the European Pharmacopoeia ........................................................................... human ..2.................6............5–4965 Alfentanil hydrochloride ........................... 1505 all-rac-α-Tocopherol...............6....................................................... 946 Adipic acid. 1139 Alcoholimetric tables (5.. hydrated......... 1519 Aluminium (2...........).......................11.. 1511 Alprostadil ............................................ Cell substrates for the production of vaccines for human use.... Cell cultures for the production of veterinary vaccines.........) .............................................. 1464 Aceclofenac.......................................................... ultraviolet and visible (2.......2.................................................................................6–5105 Acitretin ................................................................................................................................. 1473 Acetylcysteine....... General texts on microbiology .)....................... Evaluation of safety of veterinary vaccines and immunosera ...............5–4965 Alprazolam ........ 607 5.... sodium ................................... 1519 Aluminium hydroxide..... 3226 Alginic acid.......... 1481 Aciclovir......................................................................7–5641 5........................................ 685 A Abacavir sulfate................ Chemometric methods applied to analytical data ..........7–5620 Aerodynamic assessment of fine particles in preparations for inhalation (2............. for adsorption ...........................2......................................... 1508 Almond oil..22...........................................6............7................................................)... Barbados ...........................2–3897 Abnormal toxicity (2. 8......... 1497 Alendronate trihydrate..................... gas........................... Chicken flocks free from specified pathogens for the production and quality control of vaccines...............................1–3719 Abbreviations and symbols (1...... 8..... 1485 Additives................3–4275 Acetic acid in synthetic peptides (2.....................................................4...............................................................) ..) ......... 1477 Acetyltryptophan........................... 209 Adapalene ....................................... hydrated.....................................26.................... 1489 Adrenaline .... Monographs on herbal drug extracts (information chapter) ........................................................................................ 8.. 1492 Air.....20........................5........... 1487 Adenovirus vaccine (inactivated)................ 8...................... Names of herbal drugs used in traditional Chinese medicine ......................................... 8.. 1491 Adsorption.............. 2404 Alchemilla...........................................2.. 8.......24.......... 560 Altizide...................)........... 591 5................9..........................7–5617 5....... 40 Acacia ...........................................19....................................................................... 159 Aluminium magnesium silicate .. 1487 Adeno-associated-virus vectors for human use ..) .........4.....2–3945 Allium sativum for homoeopathic preparations ........................................................................................................................................) ....... plastic (3....). 8...............13.................. 1479 Acetyltyrosine......................................... 1509 Alprenolol hydrochloride ........9.....5....................................................7 Actinobacillosis vaccine (inactivated)..........2................... Metal catalyst or metal reagent residues .............. Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products .....................5–4963 Acebutolol hydrochloride ....................... Guidelines for using the test for sterility........ sodium ...............3.... 8.... 1470 Acetic acid....................................Index 5......................1................................................. 1518 Alum..... 133 Allantoin ...........................) .) .... 582 5.... N-..............6–5133 5............9........ 1494 Alanine.............................................................2....... 1839 Activated coagulation factors (2........................... synthetic medicinal.23.......................................................5–4941 Acacia....................................... medicinal ..................................................5....... 587 5..........................................6...................................................4–4709 Alteplase for injection ........................ 1460 Acamprosate calcium .............................. 1505 Allergen products ........... 8................... Substances of animal origin for the production of immunological veterinary medicinal products ................... 8........ 1136 Agaricus phalloides for homoeopathic preparations............ 1472 Acetylcholine chloride ......................2..........................................................................................................................1..........3–4205 5..................................... virgin ......... N............................... Assay of interferons ............................................ 398 Adenine......................................... 1501 Alfuzosin hydrochloride ................................................................................................ 1490 Adrenaline tartrate .............................. 945 Adenovirus vaccine (live).................................................................................. 8....................................................................... hydrated ......... 3436 all-rac-α-Tocopheryl acetate......... 1521 Aluminium oxide......... 1522 Aluminium phosphate gel ............ 8.......................... 168 Acetone ...... 579 5................ 8.............. 8...... 1504 Alkaline-earth metals and magnesium (2.................. 639 5..................... 579 5...................................................... 1466 Acemetacin .. 649 Alcuronium chloride. 132 Aluminium chloride hexahydrate................................................................................................................................... 1467 Acesulfame potassium..... 572 5......................................... 1520 Aluminium in adsorbed vaccines (2..............8... 733 5... standardised.) ...13................ Polymorphism ....................... 8......................... 579 5.. 8...................5–4911 5..........9...................... 649 5..........................).................................. 1484 5854 EUROPEAN PHARMACOPOEIA 8................ 555 5...................................... 8.................................................................................... Evaluation of safety of each batch of immunosera for veterinary use............................ 8..................................................................................................................... 1522 Aluminium phosphate.. 1469 Acetate trihydrate.............................................7........................ 309 Aflatoxin B1 in herbal drugs......... 1000 Activated charcoal ................................)................. 1461 Acanthopanax bark ...........................................................4...................... Evaluation of efficacy of veterinary vaccines and immunosera ...2–3981 Allopurinol ...........1......... 663 5.................................. spray-dried ........ 714 Adenosine ............................................................... canine... 1475 Acetylsalicylic acid .................8......................................................... Terminology used in monographs on biological products .......................).......1.....6–5213 See the information section on general monographs (cover pages) ......................................... 8.. 8..................... Statistical analysis of results of biological assays and tests... 8............ porcine ........................3–4275 Aloes.7..... Alcoholimetric tables....................... 1498 Alfadex ............5....3–4238 Aloes............................................................................6............. 128 Alkaline impurities in fatty oils (2...........4..............3–4264 Agnus castus fruit .2............ sodium............. glacial .............. 184 Absorption spectrophotometry...................................) (5....................................................... 8............................................................. 1507 Almond oil............................................. specific surface area by (2........... 8..............6–5139 5......................................................8....................... 1045 Alphacyclodextrin ................................................18...............................................25......................7–5661 5......................................26................... 1136 Acarbose ...........9...................... 1473 β-Acetyldigoxin............7–5826 Acetazolamide..........................................................................2........................2..34............................3–4239 Alovudine (18F) injection .............................................................1.....2.........................................................................................3–4408 Alexandrian senna pods .......3–4252 Alfacalcidol............ 1496 Albumin solution.......2..... 1515 Alternative methods for control of microbiological quality (5.21.............. Cape................................. determination of (2..... General texts on biological products ......7–5699 Acid value (2....... 276 Agar .4....................17...... 1141 Aloes dry extract........ Pharmacopoeial harmonisation ...................... Residual solvents ........................................ ....2–3981 Anaemia vaccine (live)......... 8........................56........................ 361 Application of the F0 concept to steam sterilisation of aqueous preparations (5....................8......38...................................................21) ....................................15............. 237 Assay of heparin (2.....2–4002 Argon .................. 271 Ash leaf ............. anhydrous ......................................... 1542 Amisulpride............................5.. 1527 Alverine citrate...................................................)..3....)................... minimising the risk of transmitting via human and veterinary medicinal products (5.............................................................. 1156 Ascorbate........................................................................7. 8..................7............) ...... 8............. 8.................... 8......... efficacy of (5.......................................... 2185 Analysis......................................1...... 279 Arnica flower..................................................... 90 Amino acid analysis (2.........3–4343 Anti-D immunoglobulin.....6...............................4....................... 272 Assay of diphtheria vaccine (adsorbed) (2........................... 1150 Anise oil ......................................................9.... 1554 Amobarbital sodium .....6–5284 Antithrombin III....... 1552 Ammonium hydrogen carbonate ................1............................ 1561 Ampicillin sodium......................................... 1529 Amfetamine sulfate ........................................7–5479 Assay of human coagulation factor II (2................ 1587 Aripiprazole.8..6–5223 Arachis oil...................7...6–5092 Analytical sieving............................ 1142 Angelica dahurica root...3–4266 Anastrozole.....................34....................9..) ..................6.........7............................................. 8.......................................... 248 Assay of human coagulation factor VII (2.................8.. 3398 Aminophylline hydrate .....................................................................) ..6–5091 Aprotinin ....................... 1571 General Notices (1) apply to all monographs and other texts Index Anthrax spore vaccine (live) for veterinary use...............2...... 132 Ash..14.......... 1553 Amobarbital ............. sulfated (2...... 351 Analytical sieving.7–5703 Ammonia (13N) injection.7.) .....) ................................................) ............................................... 8..... 1564 Ampicillin trihydrate... 1560 Ampicillin......................) ......... 1584 Arachis oil....1–3722 Aristolochic acids in herbal drugs.................. 1586 Arginine hydrochloride .............. 266 Assay of human anti-D immunoglobulin (2......................... 8...............)......... refined . 8....................6. 921 Anthrax vaccine for human use (adsorbed.....3–4187 Assay of heparin in coagulation factors (2......... 1554 Amomum fruit.................. 1575 Animal immunosera for human use ........4–4712 Arginine .... 1546 Amlodipine besilate...................................11...... 8.....................................17........................................6.............. 1570 Anemarrhena asphodeloides rhizome ..............7....... 8.........4.........)...............6–5218 Anticomplementary activity of immunoglobulin (2............................................. 1527 Amantadine hydrochloride ....34............1..................... 1145 Angelica sinensis root ...................................................... test for (2......) .............. human .. test for (2..............) (5........4.....)..........7.............................................................................2–3983 Articaine hydrochloride.............................. human...... 1731 Ascorbate.........................) ............................................. European viper venom ..............................................38..................6–5220 Aprotinin concentrated solution .....................).........14...........................8............. 984 Anaesthetic ether ... 1568 Anacardium for homoeopathic preparations............................................. 8..................... 247 5855 ..............................13.............................................................. 8............).................................................................................7........... 8.... 748 Animal spongiform encephalopathies..... human ......... 249 Antimicrobial preservation.................................................... total (2........................................................ 8.. 8.... 1157 Ash.......7 Aluminium sodium silicate .......7....................11.......................................................................20............................) .................... chicken......................2.... 249 Assay of hepatitis A vaccine (2................................ 1548 Ammonio methacrylate copolymer (type A)..................)............................................................................. 1575 Apis for homoeopathic preparations....2–4001 Arginine aspartate ............. 1593 Aspartic acid..............................5.........................................).....................................................8............5–4942 Angelica pubescens root .36.......16...... 1531 Amidotrizoate.................................. sodium ..........................6..19............. 8........................) .........................1...............................5–4966 Artichoke leaf ........................................................................................1–3710 Amoxicillin sodium............................................................ 252 Assay of human α-1-proteinase inhibitor (2.............................................................................2–3983 Apomorphine hydrochloride hemihydrate ....................... 254 Assay of human C1-esterase inhibitor (2.................. 1539 Aminocaproic acid ............................... assay of (2................2..7................... 4....................7–5617 Analysis. 1557 Amperometric titration (2............................................................ 8.2............................................17.....) ......... 1544 Amitriptyline hydrochloride .......................................... human ....................).7....... 200 Anti-D antibodies in human immunoglobulin.) ...............) .......................... 1566 Amylmetacresol ............. 127 Arsenicum album for homoeopathic preparations ................................................4....................... animal ......................... concentrated .... 8..........................................14...................................).. 592 Aniseed .......... 1555 Amoxicillin trihydrate.............8-cineole in essential oils (2.................. monoclonal ................................... 1528 Ambroxol hydrochloride ..................4... 1590 Ascorbyl palmitate.............).......... particle-size distribution estimation by (2.6–5091 Amphotericin B ..........) ....................... 230 Antibodies (anti-D) in human immunoglobulin......26.............. 8.6–5215 Amino acid analysis (2................................. 1540 Aminoglutethimide ...................... 1591 Ash insoluble in hydrochloric acid (2........) ...... 249 Assay of human antithrombin III (2..........................................) . 1147 Animal anti-T lymphocyte immunoglobulin for human use.. 1153 Arsenic (2.........5.....13........................................34............... 1047 Ammonia solution.......... 1549 Ammonio methacrylate copolymer (type B) ................... sulfated (2................2...........................56.....6–5109 Assay of hepatitis B vaccine (rDNA) (2...............26................................. 3229 Ascorbic acid ......................................... 8...................... thermal (2............7–5620 Anamirta cocculus for homoeopathic preparations .................)....................2...32..............................).... 8....................) (5.43......4–4711 Ammonium chloride................................................................ 8......................... 817 Anti-A and anti-B haemagglutinins (2............................) (5...................... 8... 215 Antibodies for human use......2.............................................7–5683 Angelica archangelica root .............................) .......................... 1151 Arnica tincture.... 169 Antazoline hydrochloride...... assay of (2.... infectious .2.............................. 8................ 1578 Apparatus (2.......17......... 759 Animal spongiform encephalopathy agents.. 2407 Anti-D immunoglobulin..................................... 753 Anticoagulant and preservative solutions for human blood ................... 1524 Aluminium stearate.....................) ...........3–4410 Amiodarone hydrochloride.................... calcium .............................................................. 8............................2–3998 Amiloride hydrochloride dihydrate . 1594 Assay of 1........................ round ....................................... prepared from culture filtrates).....................2–3983 Arsenious trioxide for homoeopathic preparations .................................................... 8............................................) (5....... anhydrous.........4.......................... products with risk of transmitting agents of ........8.............. 203 Antibiotics..................7–5618 Aminobenzoic acid... microbiological assay of (2.................................2–3996 Amikacin sulfate .................................6–5395 Aminosalicylate dihydrate.......... 1592 Aspartame................. 8..........7................................EUROPEAN PHARMACOPOEIA 8......... 560 Approximate pH of solutions (2..........) ..1–3701 Amomum fruit.................................. 1541 Aminophylline...................................7....7...........................................18.. 215 Anti-D immunoglobulin for intravenous administration...6–5213 Amikacin ................... human............... 1525 Aluminium sulfate.................... 254 Anti-T lymphocyte immunoglobulin for human use............................... 8........ 8...................... 1550 Ammonium (2..............)................................. test for (2..... 8.......................................7..........8..............................................7–5618 Ash..... 15 Apparent dissolution (2........................ sodium ..2..................12.............................................1... sodium............. thermal (2................ 8... 8...) . 557 Antiserum.......)........................................ 127 Ammonium bromide ...... 8............ 8........ particle-size distribution estimation by (2.....6–5381 Amidotrizoic acid dihydrate ..8................10........................................... 8..............................................................9.......................................................................................... 8...... hydrogenated.....................)......... 1148 Anisidine value (2.. 8......... 132 Asparagine monohydrate....................) ............................. 1033 Antithrombin III concentrate.............................. 8.......................................................................5–4896 Assay of human coagulation factor IX (2............... 1552 Ammonium glycyrrhizate ..............5–4943 Artichoke leaf dry extract............) ......................................... 8........ ...................................................... 1622 Barbados aloes ...........30.................................. 572 Baical skullcap root .............................................................2–3984 Barium chloride dihydrate for homoeopathic preparations ............................................ 8................................ fresh.................................... validation of nucleic acid amplification techniques for the quantification of B19V DNA in plasma pools : guidelines................ 229 Biological assays and tests................. 3493 Avian viral tenosynovitis vaccine (live) ..... yellow........ 265 Assay of human protein S (2.............................................................................) ..... 1621 Bacterial endotoxins (2..................................................................................................................6–5182 Benzoin............................................................................. 8........2.... 1655 Betahistine mesilate.................................. 1598 Atovaquone......) ........................... 1162 Beclometasone dipropionate................. 1596 Atorvastatin calcium trihydrate.............................................................................. 252 Assay of pertussis vaccine (whole cell) (2..............................2...) .........................................5–4971 Benzoic acid ........................................7.......2–4050 Betadex............................ 818 BCG vaccine...................................... 257 Assay of interferons (5.................................................................................. 1600 Atractylodes lancea rhizome ................24..............................7........................................................................................... 1647 Benzbromarone..41)..)........................................................... 997 Avian paramyxovirus 3 vaccine (inactivated) for turkeys............................... 1604 Atropine sulfate............ 8............................... 1167 Belladonna...............) ..............................................2...............................................................................................................................................8.... 1638 Benzathine benzylpenicillin .................................................. 1636 Benzalkonium chloride....................................................6–5184 Biological assays (2....................... 1647 Benzylpenicillin potassium ... 175 Biotin............... 995 Avian paramyxovirus 1 (Newcastle disease) vaccine (live).) .............................) ..............................5–4972 Betacyclodextrin....................................... 1637 Benzalkonium chloride solution. 8.................................7....................................................................................................................................... 1159 Atractylodes rhizome..............................)........................................................ prepared .7................. sodium .7............... 8...... 255 Assay of human coagulation factor XI (2........................................................................................5–4945 Belladonna leaf tincture.6.. standardised ............... 1670 Bilberry fruit...... 819 Bearberry leaf............. 35 Atomic emission spectrometry......... 8....................7–5684 Aujeszky’s disease vaccine (inactivated) for pigs ................................... poly(hydroxypropyl) ether .............................) .................7 Barbital............................ 8..........14............ 579 Biological products. 1641 Benzocaine..................................... 1651 Betacarotene ....................... freeze-dried........................ 1595 Atomic absorption spectrometry (2............................................................................. 266 Assay of human von Willebrand factor (2........ 1624 BCG for immunotherapy.......................................................................7–5707 Azithromycin ................. 8............... 36 Atomic emission spectrometry (2............ 1650 Benzylpenicillin sodium .3–4238 Barbary wolfberry fruit..................7–5704 Atropine .......) ....1–3659 Azaperone for veterinary use ................................. anhydrous.... 556 Biological products......2.... 1672 See the information section on general monographs (cover pages) .................................................. 932 Avian live virus vaccines : tests for extraneous agents in batches of finished product (2....................................................................................Index Assay of human coagulation factor VIII (2.. 1635 Bentonite.................................................................................................................................................................................. 8......... 1628 Beeswax............................ 1630 Beeswax.... Siam ............................................................................................4...............5............... 8. 1659 Betamethasone dipropionate............................ 926 Avian infectious bursal disease vaccine (inactivated) .........................................21...........................................2–3984 Barium sulfate .................................. 931 Avian infectious laryngotracheitis vaccine (live)...................... 1668 Bifonazole ..........................6–5186 Bilberry fruit............................20... 8.......................25....) .... 8............................................4–4705 5856 EUROPEAN PHARMACOPOEIA 8................................... 1657 Betamethasone acetate . benzathine .................. 1605 Aucklandia root ...........................................2.................... 1671 Biperiden hydrochloride...........................4–4505 Avian paramyxovirus 1 (Newcastle disease) vaccine (inactivated) ....................................... terminology used in monographs on (5......... 1661 Betamethasone sodium phosphate................ 1666 Bezafibrate ..............2....31.. 1158 Atenolol.. standardised.. 1608 Azelastine hydrochloride ....... hydrous .......................................................................... in vivo (2..........................................................3................................................... Sumatra........................... 1664 Betaxolol hydrochloride...... 923 Aurothiomalate........................................7....................................................................... 1624 Basic butylated methacrylate copolymer .16..............7.........7... 1623 Barium chloratum for homoeopathic preparations ..... 1633 Benserazide hydrochloride ......... 97 Atomoxetine hydrochloride ................ 1643 Benzyl alcohol .......... white . 921 Aujeszky’s disease vaccine (live) for pigs for parenteral administration..... 929 Avian infectious encephalomyelitis vaccine (live) ....................57.......................1......7.............................).......................) .....7.......... 1610 B B19 virus (B19V)...............................6–5183 Bilberry fruit dry extract............. 8.... 194 Bacterial endotoxins................................... 3230 Aurum chloratum natronatum for homoeopathic preparations ........) .........................7....... procaine ..10........................ 1631 Bendroflumethiazide.............. 8...................................... refined and standardised ..................... 1653 Betacyclodextrin .......).....)..........1..................................................................................................................... 1630 Belamcanda chinensis rhizome........... 1165 Belladonna leaf dry extract............................................................... 1619 Baclofen ....7–5711 Betamethasone .) .. 1163 Belladonna for homoeopathic preparations.................................2–3984 Avian infectious bronchitis vaccine (inactivated).................25....... guidelines for using the test for (5................................................................................ 1640 Benzenesulfonate (methyl....................................................................... 255 Assay of tetanus vaccine (adsorbed) (2......................................................................................) ........................................................................................ 242 Assay of poliomyelitis vaccine (inactivated)..............................)...).........5...........22............................... 8.................. 8.................................................7......................... 8........... inductively coupled plasma(2... 8.................. statistical analysis of results of (5.......................... Siam........ 1160 Atracurium besilate ........ 1626 Beclometasone dipropionate monohydrate.. 607 Biological indicators of sterilisation (5................ 1663 Betamethasone valerate .......................................................1–3693 Avian tuberculin purified protein derivative...................................................... 935 Avian viral vaccines : tests for extraneous agents in seed lots (2....................................................6....................................... 579 Biological tests (2........................................ 1646 Benzylpenicillin............................ 8..5–4972 Betahistine dihydrochloride.....................................................)................ 1170 Benzoin tincture........................................ largehead ............................ 242 Assays (2..................................................................................).........2–3921 Bacampicillin hydrochloride ........................................... 8..................................... Sumatra..... 1615 Bacitracin................................19.........2–3930 Assay of human plasmin inhibitor (2...................6........... 925 Avian infectious bronchitis vaccine (live)... 1645 Benzyl benzoate ................ 1171 Benzoin tincture... 1607 Azathioprine.6–5206 Belladonna leaf....... 261 Assay of human protein C (2......................... 8...)................ fresh...).........................6........................... 8............7–5470 Benzethonium chloride ....... 1172 Benzoyl peroxide.....................................1............ dried .................................2–3929 Assay of human coagulation factor X (2...................................................................................... 1161 Bambuterol hydrochloride ... 8..... ethyl and isopropyl) in active substances (2......................... 928 Avian infectious bursal disease vaccine (live) .. 1633 Benperidol ............................... 155 Astragalus mongholicus root ............................................................... 1643 Benzoin............................... 1648 Benzylpenicillin. 1168 Benazepril hydrochloride ....) ..........7................................................ 8....................................22...... 8...........................6................................................................................... 1617 Bacitracin zinc..) ................................. 1667 Bicalutamide................ general texts on (5.................................................................. 8............................ 663 Assay of pertussis vaccine (acellular) (2.............................................................................23............................................. .............) ................ 1329 Black cohosh...............) ........................................ 1695 Bronchitis vaccine (inactivated).. 971 Camphor.................................. anhydrous................. 1676 Bismuth subnitrate...... 1176 Bitter-fennel herb oil .. 1749 Calcium pentetate (sodium) for radiopharmaceutical preparations .... 8................................... anticoagulant and preservative solutions for ...............................................................................................)..................3.................... 1706 Bursal disease vaccine (inactivated).............. 1682 Botulinum antitoxin ........................... 1722 Calcipotriol monohydrate ................. 1676 Bismuth subsalicylate.............. 1774 Calcium chloride dihydrate....... sets for the transfusion of (3............................................................................................. 1703 General Notices (1) apply to all monographs and other texts Index Buprenorphine ................ 1175 Bitter fennel ................................................................................................. 1705 Buprenorphine hydrochloride ..... 970 Calicivirosis vaccine (live)..... 1744 Calcium lactate trihydrate ................................................................................................................ 926 Brotizolam ........................................................... 1681 Borax ............................................................. 8..................................... 937 Bovine parainfluenza virus vaccine (live).............................2.... 1751 Calendula flower......... 1744 Calcium lactate pentahydrate................... 940 Bovine rhinotracheitis vaccine (live)........... 1173 Bisacodyl..............................2–4007 Bromazepam .............................. anhydrous .... heavy ................. 1740 Calcium hydrogen phosphate....... avian ..............................................................................2–3985 Cadmium sulfuricum for homoeopathic preparations................................. 8................................................... 8........) .................................................................................................... 1726 Calcitriol ........................................ 8...................................................... 1680 Blood and blood components.........................................7–5685 Boldo leaf dry extract.......................................................................................... 1697 Bufexamac ........................) ..... 1683 Botulinum toxin type B for injection .................................................................................................................................................................................... 1192 Butylated methacrylate copolymer...... 418 Bogbean leaf ........................................................................................................ 1738 Calcium gluconate for injection ...1–3702 Blackcurrant leaf ......................................................... 1753 Candesartan cilexetil ................................7 Biphasic insulin injection .......6–5229 Bromocriptine mesilate... 1724 Calcitonin (salmon)........... 1684 Bovine insulin ......................................... 1743 Calcium lactate monohydrate .............................15..........6–5297 Bovine leptospirosis vaccine (inactivated) ................................. 1745 Calcium levofolinate pentahydrate........................................................2–3985 Calcium iodide tetrahydrate for homoeopathic preparations ......... 1187 Boiling point (2.............5.............................. 1692 Bromperidol decanoate.............................. 1734 Calcium glucoheptonate ................................................ 1717 Cachets......................................................................... 8..............................6–5175 Calcium phosphate..........4............................... 1678 Bistort rhizome ........................................................................................................................................ 8....................................................................................... infectious.......................................6–5230 Buspirone hydrochloride ......................................................... 3494 Bovine viral diarrhoea vaccine (inactivated) ...................... 1709 Busulfan ................34.......... sterile containers of plasticised poly(vinyl chloride) containing anticoagulant solution (3................................... 1682 Bordetella bronchiseptica vaccine (live) for dogs.................................................................... 8................. 1740 Calcium hydrogen phosphate dihydrate.... human..... 1186 Black horehound.................................. 418 Blood and blood components....................................... 936 Boric acid........................................ anhydrous ..................................... 943 Calf rotavirus diarrhoea vaccine (inactivated)...... 1743 Calcium in adsorbed vaccines (2............................. 1745 Calcium levulinate dihydrate ..................................... 8.....................................................5–4946 Bitter-orange-epicarp and mesocarp tincture......................... 2493 Biphasic isophane insulin injection. 781 Cadmium sulfate hydrate for homoeopathic preparations............................ 1711 Butcher’s broom .......... 795 Buckwheat herb ......... 159 Calcium iodatum for homoeopathic preparations ................................................................................................... 8................................................................................................ 944 Calicivirosis vaccine (inactivated)................4. feline ... 938 Bovine respiratory syncytial virus vaccine (live) ...........................5–4901 Bumetanide ................................ 415 Blood.............................. materials for containers for (3..... infectious................................... 1693 Brompheniramine maleate .................... 8............... 1729 Calcium ascorbate ..............................................................................2–3985 Caffeine .......................................................... 1185 Bleomycin sulfate...9...................................................................................... 946 Canine distemper vaccine (live) ..... 8............ 945 Canine adenovirus vaccine (live)........................... 1754 Canine adenovirus vaccine (inactivated)..............7–5602 Buflomedil hydrochloride...5–4887 Boldo leaf.......................1.............................................2......2............6.............................. 1675 Bismuth subgallate.............. 983 Bovine serum .................. 2493 Birch leaf ........................ 1241 Bitter-fennel fruit oil .................) ..................................... 375 Blood and blood components..................... 1177 Bitterness value (2............................................... refined .................................................................................................................................................................................................. 127 Calcium acetate...................6–5218 Blood........... 1180 Bitter-orange flower.................. anhydrous ...................... infectious..... 947 5857 .................................. 417 Blood and blood components................. D-........................... 276 Bitter-orange epicarp and mesocarp ...................4–4715 Bupivacaine hydrochloride............................... 8.......................................................................................................................................... sterile plastic containers for (3..3............................................ 1700 Bulk density and tapped density of powders (2....................... 1728 Calcium (2............ 925 Bronchitis vaccine (live)........................................... 8...............................................................................................1............................. 1 strain) for veterinary use......................... 1673 Bismuth subcarbonate..... 1731 Calcium carbonate............ sodium ................................................................................................................................ 1732 Calcium chloride hexahydrate .. 1624 Butylhydroxyanisole ................................. 8.... basic ........................... 1190 Budesonide ..)...... 1731 Calcium carboxymethylcellulose ....................................... 1750 Calcium sulfate dihydrate......................................... 1718 Caffeine monohydrate...........3..................8.................................. infectious ..................... 8..... 1686 Bovine tuberculin purified protein derivative........................ 1719 Calcifediol...............................................2........ anhydrous ..7–5687 Borage (starflower) oil...... 8........ 1737 Calcium gluconate........................................... 1677 Bisoprolol fumarate ................................................................... 1736 Calcium gluconate .............. feline ...................................... 1714 Butyl parahydroxybenzoate...............................12...... 1720 Calcipotriol. avian..7–5712 Bromperidol . avian ............... 3233 Calcium folinate.................. 1696 Brucellosis vaccine (live) (Brucella melitensis Rev................................................ racemic .................. 941 Brimonidine tartrate .......... 8.... 1748 Calcium pantothenate .... 1193 Calf coronavirus diarrhoea vaccine (inactivated)......................................... 8................................................... 8.................14....................................................... 1687 Bromhexine hydrochloride.................................. 1733 Calcium dobesilate monohydrate ....................)........................................... 1712 C Cabergoline ..........................................................................................................................)......................... 1029 Botulinum toxin type A for injection ............... 1739 Calcium glycerophosphate ................5......................... 8............................................................................) ..................................................................3–4279 Camphor..........................................1................... 928 Bursal disease vaccine (live).................. 1733 Calcium edetate.....................................................................) ...........................................................2.......... 8.............. 1749 Calcium stearate ............. avian....................6–5169 Buccal tablets and sublingual tablets................................. 1742 Calcium hydroxide ..................................5–4973 Buffer solutions (4................................................................. 1181 Bitter-orange-flower oil........................................................................................... 1713 Butylhydroxytoluene ..............................................................................................2–3985 Calcium lactate.........................................................EUROPEAN PHARMACOPOEIA 8........................................ infectious..................................................... empty sterile containers of plasticised poly(vinyl chloride) for (3......................................................... 929 Buserelin .................................................................... .... 787 Capsules............ medicated................ 2664 Castor oil... 780 Capsules.......... refined and standardised ............................................................................................4–4719 Carbimazole ....... 258 Cefaclor.......... 8............... 780 Capsules............................. 1210 Ceylon cinnamon leaf oil..............1–3814 Cetrimide.................................... 8.....2... 1788 Cefalotin sodium ............................................................. 8.............7 CD34/CD45+ cells in haematopoietic products..2.......................................... 1839 Chemometric methods applied to analytical data (5.................................................................................... 1757 Capsicum ..............................................................................................7...................).................................................... 8.......................................) .......... 795 Capsules.........................................4–4722 Carrier proteins for the production of conjugated polysaccharide vaccines for human use (5....................................... 1815 Cefuroxime axetil .......................................................................................... 1781 Cascara............7–5779 Cellulose...................................9......11..........................................................1–3731 Cellulose acetate butyrate ............ 984 See the information section on general monographs (cover pages) ........................................................... 1775 Carisoprodol................. emulsifying ......................... 1758 Caraway fruit....... 106 Characterisation of preparations for nebulisation (2............................................ 3234 Caprylic acid ........................................................................... 8.......................25......................47................................ 806 Capsules.......................... 1774 Carboxymethylcellulose sodium........9..................................................................... 8................................................ polyoxyl..........................................................................7........................................ 813 Captopril ........................................................................ 951 Cape aloes.................................................) (5..................................................................................)......... low-substituted................................23.... Roman ................ 780 Capsules..33.....................3–4283 Cellulose.......... in distributor for veterinary use ............................................ 8.......... 263 Cell cultures for the production of veterinary vaccines (5.....................................................1–3727 Capillary electrophoresis (2... 1786 Cefalexin monohydrate....................................................................8....) (5....................7–5617 Capillary viscometer method (2.. 1831 Cetostearyl alcohol . 1807 Cefradine .......................................... 1837 Cetyl palmitate.. microcrystalline ................................................................................................................................................................................................................................................... 285 Capsules and tablets.......).............................................................................................................................. 8............................ 948 Canine parainfluenza virus vaccine (live) .. 781 Chewing gums............. 1774 Carmellose sodium....................7................7–5779 Carmellose sodium............................................... 1791 Cefapirin sodium. 949 Canine parvovirosis vaccine (inactivated)..................9........ soft.................... 1198 Capsules . sodium ........................................................... standardised.................................................................)........................ 1766 Carbomers ............................... sterile ....... 1203 Castor oil................................................. 1206 Characterisation of crystalline and partially crystalline solids by X-ray powder diffraction (XRPD) (2......................... 1836 Cetyl alcohol....... 1823 Cellulose acetate phthalate (5.... cross-linked ..... disintegration of (2......................... 1048 Carbon monoxide in gases (2... 1809 Ceftazidime pentahydrate.................................................... 582 Cellular products................. medicated .................. 1824 Cellulose (microcrystalline) and carmellose sodium........ 8..................Index Canine leptospirosis vaccine (inactivated) .....3–4281 Castor oil.................................... polyoxyl hydrogenated..........................5...) ............... low-substituted.....7–5618 Capsules............................................... 811 Chewing gums....... 1818 Celandine...................................... nucleated (2.....................2...........1... 1813 Ceftriaxone sodium....................................... microbiological control of (2........ 1141 Capecitabine.) ........................ modified-release ..................................... refined ....4–4721 Carmellose.................11.................................................................................................... 780 Capsules............................................................................. 339 Characterisation of crystalline solids by microcalorimetry and solution calorimetry (2............................................. 363 Characters section in monographs (5........................................3–4282 Catgut............................1–3734 Cetostearyl alcohol (type B).... 1762 Carbidopa ................................................. 1199 Caraway oil . 1268 Celecoxib ................................................ hard ....... 1780 Carvedilol ................... emulsifying ........... 216 Cellulose acetate (5.............. 1793 Cefazolin sodium..................................... 325 Chicken anaemia vaccine (live)....................................................................................................................3–4280 Carmellose sodium and microcrystalline cellulose.................7–5717 Celiprolol hydrochloride ......................................................7–5641 Chenodeoxycholic acid ......... 1200 Carbachol................................ gastro-resistant .............) .................... 1196 Capsicum soft extract......................................................................................................................................................................2. 8.................................................3......... 8.......24........7–5621 Cellulose acetate ... 262 Chamomile flower.... sodium.................................. 8..................... 27 Caprylate. 8....... 8............. 1817 Cefuroxime sodium.................................... 1760 Carbamazepine ............. 8............................................................. 695 Charcoal................................ greater............................ 1773 Carboxymethylcellulose calcium .... 1778 Carrageenan ......6–5235 Carbon dioxide ................................29.........1.............)..................................... vaginal.. virgin .............. dissolution test for (2....25......).......6–5184 Cetirizine dihydrochloride ........ 1799 Cefoperazone sodium ..............1–3735 Cetostearyl isononanoate .................................................................................28..... activated ...... 1969 Carboxymethylcellulose sodium..........................................................................) ......................... 1211 CFC assay for human haematopoietic progenitor cells (2.............................................. 1771 Carboxymethylcellulose................................................................................. disintegration of (2......................) ....................... 162 Carboplatin................ 8..........................................8............. 1828 Centaury ..............................3–4280 Carboxymethylcellulose sodium........................... 8............................... 8....... 1127 5858 EUROPEAN PHARMACOPOEIA 8. 8.......................................... rectal ....................... 1785 Cefadroxil monohydrate...... 1776 Carnauba wax...........) ....................................................5............................... 1796 Cefixime.........) .......................................................... hydrogenated..... 1770 Carboprost trometamol ....................................................... 1811 Ceftazidime pentahydrate with sodium carbonate for injection .........................................................................................) .....................8.........................................27......... 1775 Carmustine .......................... 8..............) .............................. standardised ................................................................................................... 1782 Castor oil.................. 1838 Cetylpyridinium chloride .................6–5236 Carprofen for veterinary use ......... 1756 Caprylocaproyl macrogolglycerides .) .........................2........................................................................... 8......................... intrauterine ...................................) ......................................... 1197 Capsicum tincture.... 1789 Cefamandole nafate.............................. oromucosal........ 1773 Carmellose calcium .........2........................................................................... standardised .......................................................................... 1803 Cefpodoxime proxetil ............................................................... 1833 Cetostearyl alcohol (type A).................... infectious .......... 1840 Chewable tablets ................................................................................................... 1768 Carbon dioxide in gases (2.... 8.....................................................................................................44......................3–4205 Carteolol hydrochloride...... 1204 Centella ..... 1769 Carbon monoxide (15O) ........ 161 Carbon monoxide........ 79 Capillary electrophoresis (2...............47...................................................61.............................. 1194 Capsicum oleoresin..................1–3729 Cefepime dihydrochloride monohydrate .... 8.......... sterile.........9............)........................................... 1801 Cefoxitin sodium .. 779 Capsules and tablets...............................9................................... 2665 Castor oil.......... 1820 Cell count and viability........ numeration of (2.................6–5133 Cell substrates for the production of vaccines for human use (5..4–4723 Cetostearyl sulfate............................8...................... 8................) .......).......7–5621 Cellulose acetate phthalate .....6............ 1792 Cefatrizine propylene glycol.........................................................2.................... 1805 Cefprozil monohydrate ....................................................................9.......... 1202 Cassia oil ........ 8.....).................. 8............................. 1800 Cefotaxime sodium ............................................................ 8............................................................. 1117 Catgut.....4.......................................................................................... 8.................. 1838 Ceylon cinnamon bark oil ..1–3728 Carbocisteine..21....................................... 950 Canine parvovirosis vaccine (live)....... 8................. 1201 Cascara dry extract........... 1761 Carbasalate calcium.. powdered ........................ .10....................................................... prepared in cell cultures) .....................................2–4012 Cholesterol for parenteral use ............ 1856 Chloroquine phosphate ........... assay of (2.................................. 1914 Clobazam ............29.......... 1874 Cholesterol in oils rich in omega-3 acids.................... 954 Clostridium perfringens vaccine for veterinary use..... 67 Cisatracurium besilate ..............................................................................................................) ..................... Ceylon.............7–5760 Coagulation factor XI....................... 1897 Citalopram hydrobromide..... 151 Chondroitin sulfate sodium ..........................1–3738 Clematis armandii stem .....)....6–5237 Ciclesonide ...... anhydrous.................... 8.............................7................. 8............................... paper (2...................................) .......................3–4175 Chromatography......................... 8.. 1927 Clopidogrel hydrogen sulfate .....................................).................. 1869 Cholecalciferol concentrate (powder form) ............................................ oral)........................ 8.......6........................... 1919 Clofazimine .......................................................... 1920 Clofibrate ....... 209 Coagulation factors..........................................11.... 952 Clostridium chauvoei vaccine for veterinary use .......................................................... 8. 8.................. 421 Clotrimazole................ freeze-dried...........................) ...................... 972 Chloral hydrate ...........................................................................................2.............................. 1930 Clostridium botulinum vaccine for veterinary use .................................. 8...................................) ......). for powders and for freeze-dried powders...........7........................ 8.......... 255 Coagulation factor XI......7–5622 Citric acid................ 8....................... 394 Closures for containers for aqueous parenteral preparations................45............ 1900 Citric acid..........1........ 1911 Clindamycin hydrochloride .. 1858 Chlorpromazine hydrochloride ............ human ........................................... 1209 Cinnamon bark oil............... 1912 Clindamycin phosphate ........................... 1847 Chlordiazepoxide............................. 21 Clary sage oil ......22...4–4725 Ciprofloxacin hydrochloride ............... 8.................................................................................. 1213 Classical swine-fever vaccine (live................................... assay of (2................ feline ................................................... 1855 Chlorocresol ........................EUROPEAN PHARMACOPOEIA 8........................) ................ 8............ 72 Chromatography................................................................................................1............... plastic (3..................... assay of (2............2–4013 Cilazapril...........................2.........2.............................) ........................................................ 1216 Cloxacillin sodium ............ 1049 Chymotrypsin .............. activated (2................................ 1899 Citalopram hydrochloride ........................ assay of (2.........................2........... 955 Clostridium septicum vaccine for veterinary use..... human........... human ... 1904 Clarity and degree of opalescence of liquids (2............................ human ..............................................................41...................2............. 8. 1019 Clazuril for veterinary use..................................... total (2..........12.................... 1215 Clove oil .......11... 8.......28............... 1891 Cineole in essential oils.......8................................................................................................8.................... 1921 Clomifene citrate ..............7............................................................... 2077 Closantel sodium dihydrate for veterinary use................. 980 Cholera vaccine (inactivated..... human ... human ........ 1922 Clomipramine hydrochloride .......................7................. 1849 Chlorhexidine diacetate . 8.............. human................ 1881 Ciclosporin ..6–5286 Coagulation factors......................) ............................. 1933 Clozapine ................................................. 1934 Coagulation factor II................................................................................ Ceylon............................... 247 Coagulation factor VIII..9................. 8.......) ...........................8...................... 1876 Chromatographic separation techniques (2....... assay of (2.... 8..................18..........) .............................)........................... 8.................2...... 1890 Cinchona bark............................... 1861 Chlorprothixene hydrochloride.....2....................4... 3450 Chloramphenicol . 1....................4.......................................26............................................. silicone elastomer for (3............... gas (2......................2................................ human............................. 1855 Chlorobutanol hemihydrate ............... 8.................................. 1332 Cinnamon...............9.......................................19......................................................................................................... polypropylene for (3....2–3930 Coated granules ....... fowl ............................ 8.........3–4343 Coagulation factor VII.. anhydrous (5...................... human .................................... 1908 Clemastine fumarate .......................................................... 1926 Clopamide ..............................4..............1–3737 Citronella oil......... 8................. 1845 Chloramphenicol sodium succinate........................................... 1879 Ciclopirox ...) .............................) ..............................................).... 786 Coated tablets..... 2408 Coagulation factor VII.) ........................................7.................... 8. 1870 Cholecalciferol concentrate (water-dispersible form). 249 Coagulation factor VIIa (rDNA) concentrated solution..... 1893 Ciprofloxacin........) ..........................2–3929 Coagulation factor VIII (rDNA)........................... 821 Cholera vaccine (inactivated).................................................................. 8................................................. 127 Chlormadinone acetate...... 1925 Clonidine hydrochloride................. 953 Clostridium novyi (type B) vaccine for veterinary use............................. 1903 Clarithromycin.................... 1867 Cholecalciferol concentrate (oily form).................. 1863 Chlortetracycline hydrochloride. 1915 Clobetasol propionate ...... 1212 Cladribine ........................ 1857 Chloroquine sulfate .......................................... 1885 Cimetidine ....4–4723 Chlorides (2.......................3–4284 Chlorhexidine digluconate solution .................. 2415 Coagulation factor X...................................................................................................) ..................................................................... 8.......................................................2.....................................................................................................................7 Chicken flocks free from specified pathogens for the production and quality control of vaccines (5....................................................................................................................................... liquid (2................. size-exclusion (2......................................................................................................................... 8.... 2414 Coagulation factor VIII.................................................................. 810 5859 ................................) ...............7.................................................................................. 248 Coagulation factor IX (rDNA) concentrated solution............4–4530 Closures and tubing............ assay of (2. 42 Chromatography.................... human ................................ dipotassium..................................................................................................................................................................................................................................................................................... anhydrous....................................................... 1883 Cilastatin sodium....................... 1207 Cinchona liquid extract........... 1916 Clobetasone butyrate........................................... 822 Cholesterol................. 1892 Ciprofibrate .............. 8...................2.. 43 Chromatography.................................. 8.........3–4286 Chlorhexidine dihydrochloride ....) . 1843 Chloramine..................................7–5722 Clonazepam.............7–5718 General Notices (1) apply to all monographs and other texts Index Cisplatin.....22........................... 8........... 8.....7–5622 Citric acid monohydrate ...........................2–4011 Chlorobutanol...................... assay of (2.....2..... 1844 Chloramphenicol palmitate...............) ... 1211 Cinnarizine...................... 272 Cineole type niaouli oil..................................................................... human........ 1865 Cholecalciferol ............................46.... 388 Closures and containers for pharmaceutical use..............................3–4288 Chlortalidone ................... human..3–4290 Clioquinol..... rubber (3.......4–4727 Circular dichroism (2.. 1208 Cineole ...................... 1841 Chlamydiosis vaccine (inactivated).................... assay of heparin (2...................................................... 1872 Cholera vaccine. 1880 Ciclopirox olamine ......................................2.............................. standardised .................................. 1906 Clebopride malate ................................ 1931 Clove........ 8.....................4–4728 Clodronate disodium tetrahydrate . 1842 Chlorambucil ..... 1857 Chlorphenamine maleate .. 579 Chitosan hydrochloride .............................................. 1859 Chlorpropamide .........................................)...32....... 2416 Coagulation factor IX......4...........................) .......................................6...............8-...................6–5239 Cinchocaine hydrochloride ........................................................................................................................................................... 46 Chromatography....... 1928 Clorazepate.........1.................................................... 1848 Chlordiazepoxide hydrochloride ..... 1846 Chlorcyclizine hydrochloride........... 42 Chromium (51Cr) edetate injection ................................................. 821 Cholera vaccine........)....................6–5238 Cimetidine hydrochloride .....................30........................................2.............................................. 1210 Cinnamon leaf oil..... 72 Chromatography............... 957 Closures and containers for parenteral preparations and ophthalmic preparations..........1–3736 Citric acid monohydrate (5.) ..)........................ thin-layer (2............................................................................... supercritical fluid (2...................................27....................................7............ 1214 Clenbuterol hydrochloride .........2................5–4896 Coagulation factor IX.... ............... ammonio methacrylate ... 388 Containers and closures for pharmaceutical use........................1.........................2.......................).....7–5699 See the information section on general monographs (cover pages) ................. 2660 Copolymer. 2174 Conjugated polysaccharide vaccines for human use.... 1222 Creams ............. 2730 Copolymer (type A)................................... 403 Containers for solid dosage forms for oral administration.............. 1935 Coccidiosis vaccine (live) for chickens .6............ neonatal piglet .........2.. 1219 Common stinging nettle for homoeopathic preparations................................. 994 Colistimethate sodium....... 22 Common selfheal fruit-spike ...2....................................... ammonio methacrylate....... 8........... 185 Contamination...... 560 Copolymer................................ 339 Crystalline solids..........1..............................................................) .... methacrylic acid .... 8.......1...................... 59 Coneflower herb......................................................7–5618 Content uniformity of single-dose preparations (2............................................. 2729 Copolymer......................................2............. alternative methods for (5...... 8.......... 1957 Cold-water vibriosis vaccine (inactivated) for salmonids......................6–5101 Compressed lozenges ....................... 1969 Crospovidone (5.......................).. 1219 Coloration of liquids (2.............................. plastic............ 415 5860 EUROPEAN PHARMACOPOEIA 8............................2.............................4–4511 Containers for human blood and blood components......................9................4–4763 Concentrates for injections or infusions....................)......................... hydrophobic ..........................1. 414 Containers for aqueous solutions for intravenous infusion............................................................... 1962 Copper acetate monohydrate for homoeopathic preparations .................13......................... pale...........) ......................................8.............5..............10..........6................................6........... 808 Cresol.....3–4408 Colloidal silica. microbial : test for specified micro-organisms (2... 418 Contamination.............................2–3988 Cuprum metallicum for homoeopathic preparations..............................) ........).......38........) (5................................. sterile (3.............. 106 Crystallinity (5.....................................) ..........................................4.... 417 Containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution............... 8......... 298 Control of impurities in substances for pharmaceutical use (5.................... 1345 Coneflower root...........1....) . materials based on plasticised poly(vinyl chloride) for (3.............................................................. glass (3............. measurement of (2............... 8..................... 158 Composition of fatty acids by gas chromatography (2.......................) ......Index Cocaine hydrochloride............................................... 375 Containers for human blood and blood components..........) ....... 8............... methacrylic acid .......4–4525 Containers for preparations not for parenteral use.................)...............................................2–3987 Cromoglicate................... microbial : test for specified micro-organisms (2.......... purple ...............................1.................... 1549 Copolymer (type B).......................... 1968 Crocus for homoeopathic preparations ............. materials based on plasticised poly(vinyl chloride) for (3.......................................... 8..6.................) ........................... polyethylene with additives for (3........................13...................................................................... 8................... materials based on non-plasticised poly(vinyl chloride) for (3...................28.......................................................................4–4516 Containers..........) ..........4–4730 Codeine...............4.......1................. 189 Contamination...)........... 1971 Crystalline and partially crystalline solids..................... 1939 Codeine phosphate hemihydrate ........................................................7–5622 Crospovidone .....................2–3991 Comparative table of porosity of sintered-glass filters (2........3–4205 Consistency by penetrometry.................. 1941 Codeine phosphate sesquihydrate .......) ....... 1965 Copper tetramibi tetrafluoroborate for radiopharmaceutical preparations ................... 1950 Cod-liver oil (type B) ....................... 1964 Copper sulfate pentahydrate ............1......................................... plastic (3....... farmed............2..5....... carrier proteins for the production of (5.........) ............... 8...............8.........................................2..................29............. plastic (3......10............ 8.............. 8........ narrow-leaved .......................12........... 1359 Conjugated estrogens .... 384 Containers for parenteral preparations and for ophthalmic preparations.................................................................................................................16................... methacrylic acid ........33....................................4–4730 Colloidal anhydrous silica ..... 8.................................. 3240 Croscarmellose sodium ...........6–5099 Composition of fatty acids in oils rich in omega-3 acids (2................2............) ..................1............. 1968 Couch grass rhizome.................. purple......2.... 15 Complexometric titrations (2.................................) ......... 1357 Coneflower root.................. 1327 Coneflower root...........................................4–4518 Containers for human blood and blood components......... 1218 Colchicine......................................................... for external use ............. 8............9....................... 1942 Codergocrine mesilate .......................) ................61....... 299 Containers (3............................................. polypropylene for (3........... methacrylic acid .......1...............12.................6.......................1............................ poly(ethylene .............4–4692 Concentrates for intrauterine solutions ................... 943 Cortisone acetate ........) ................... 8..............8................)....... basic butylated methacrylate ...................3..) ............ 795 Concentrated solutions for haemodialysis ........... absorbent ...................... 391 Containers for aqueous solutions for infusion........... 8....... materials for (3....................................................................................................................... 787 Conductivity (2....1..................................................................1..............................................).....................3–4266 Coconut oil.........2.) . 8.....2–3963 Coronavirus diarrhoea vaccine (inactivated).................methyl methacrylate (1:2) ............2......... polyethylene without additives for (3..) (5................................ 8......................1.........................................................................4–4530 Containers and tubing for total parenteral nutrition preparations..9..... 689 Control of microbiological quality.......................... 1023 Colestyramine ..........) ...............7–5699 Copper sulfate.......................................... 8..)...... materials based on non-plasticised poly(vinyl chloride) for (3................1. 383 Containers for pharmaceutical use......................) ..............6–5173 Coriander...7–5618 Contamination..................................1...............................1–3694 Cocculus for homoeopathic preparations .......... 8. 262 Colophony ...... 1959 Colibacillosis vaccine (inactivated).......2................... polyethylene terephthalate for (3............ 8...........6.....................................................).......................9..... 992 Colibacillosis vaccine (inactivated).....3–4292 Cocoyl caprylocaprate........................) ....................................... 8...................................... 1954 Coix seed.....ethyl acrylate (1:1) dispersion 30 per cent .............. characterisation by microcalorimetry and solution calorimetry (2..4...6–5241 Crotamiton ......................................................) .............14.......... anhydrous...................................................... empty sterile (3..........7 Containers for non-injectable aqueous solutions.......................... 8..........4................ hydrogenated .......) ............... 8.................................................... 8....................... 2728 Copolymer.............................. 3221 Colony-forming cell assay for human haematopoietic progenitor cells (2.)....................................... grafted............ sterile (3..............11. neonatal ruminant...... microbial : microbial enumeration tests (2........2............................... 3218 Colloidal hydrated silica .......................2....7.......1. 8............ materials used for the manufacture of (3.. sodium....methyl methacrylate (1:1) .................. 1944 Cod-liver oil.........2–3988 Copper for homoeopathic preparations ........................... 8.........................22. calf .................. 8......1...... crude ........................)............) .5....... 375 Containers of plasticised poly(vinyl chloride) for human blood and blood components.............................2–3963 Coriander oil .............vinyl acetate) for (3..................... 1217 Cola ... macrogol poly(vinyl alcohol) .....................................................15) .................... microbial : microbial enumeration tests (2........................ 1967 Cottonseed oil................... 8............... 1938 Codeine hydrochloride dihydrate....................) .................. 3220 Colloidal silver.... 1965 Cotton....... refined..............7...................... 1960 Colistin sulfate ............................)...... characterisation by X-ray powder diffraction (XRPD) of (2......11......... 2727 Copolymer.....6.2......... 1550 Copovidone ...................... 723 Cuprum aceticum for homoeopathic preparations......4–4514 Containers for parenteral preparations and for ophthalmic preparations.................................................... 409 Containers and closures for parenteral preparations and ophthalmic preparations........ 1624 Copolymer................... 8................ 1946 Cod-liver oil (type A)........... 8...................................ethyl acrylate (1:1) .......11........................... ...................................... 790 Cutaneous patches ........................................... 1987 Dalteparin sodium..................................) .............................................)..... 1995 Demeclocycline hydrochloride ........ 2000 Desflurane........................................... 8........................ 1051 Cyanocobalamin ............. 3-O..................................................................................................................................................................7–5729 Dihydroergotamine mesilate...............................................................................4.................................................................................................................. 2018 Dexpanthenol............ 8........................... 157 Determination of primary aromatic amino-nitrogen (2............................. 2008 Detection and measurement of radioactivity (2.................... 1980 Cystine ..2.................................................................................................................................................. 2058 Dihydrostreptomycin sulfate for veterinary use ............ 807 Cyanocobalamin (57Co) capsules ..................................... molecular mass distribution in (2......................................... 2026 Dextropropoxyphene hydrochloride................................2–4020 Dicloxacillin sodium ................. 1227 Digitoxin ..................... 823 Diphtheria and tetanus vaccine (adsorbed................ hydrated ....................... 2042 Diethylene glycol and ethylene glycol in ethoxylated substances (2.....................6........................................ 1993 D-Camphor ................... 2059 Dihydrotachysterol ........................ 807 Cutaneous application.......9.....1–3705 Diosmin ........................ 2049 Dihydralazine sulfate... 2021 Dextran 60 for injection ......... 31 Detomidine hydrochloride for veterinary use .... 2045 Diffraction...................................... 2014 Dexamethasone sodium phosphate................................) ..............................11............5–4901 Density of solids (2... 60 Dextrin ..................... bulk density and tapped (2............................................ 2025 Dextromoramide tartrate ......... 2022 Dextran 70 for injection .................................... 1049 Cyanocobalamin (57Co) solution ..............................................................................) ...... (Ramon assay) (2.....................................................................................................................7–5727 Dibutyl phthalate ................ particle size analysis by (2...........................................25...) ........................................................................................... 2007 Desoxycortone acetate ........................................................ 1982 D Dacarbazine.................................1............................ 8................. 8............................................................... 2004 Desloratadine ........................................ 8..5. 2066 Dimethylaniline..................................................................................... 8..........4–4497 Dip concentrates .......... 3241 Cyclizine hydrochloride..... 1992 Daunorubicin hydrochloride ...................... 2028 Diazepam......... 8......) ............................................................................................. 8........................6.......................................) .....................................................7 Cutaneous application...........(2.........2...5............................................................... 1988 Danaparoid sodium................................. 146 Dimethyl sulfoxide ......... 8.................8................................................................................ 276 Determination of metal catalyst or metal reagent residues (2..................................................4.....)..................................................... 826 5861 ..... 2019 Dextran 1 for injection..................... 2068 Dinoprostone .................. 814 Diphenhydramine hydrochloride .................................4................................................................................................................................2–4016 Cyclamate................ 2070 Dinoprost trometamol ...........3–4221 Diphtheria antitoxin.........................4............................ 2061 Diltiazem hydrochloride.............. 2067 Dimetindene maleate ...... 333 Difloxacin hydrochloride trihydrate for veterinary use....... 789 Cutaneous application........................... 1981 Cytarabine ............................................. 133 Determination of nitrogen by sulfuric acid digestion (2............................................................2–4019 Diclofenac sodium.....7–5732 Dihydroergotamine tartrate ....................................................... 2038 Dicycloverine hydrochloride...2.............................. liquid preparations for .....) .......26......................................................66........................................... 1223 Dandelion root.... 2039 Didanosine ..... 2048 Digoxin ........................ 2027 Dextrose..........6–5247 Demonstration of uniformity of dosage units using large sample sizes (2................. 1976 Cyproheptadine hydrochloride............... 261 Diphtheria and tetanus vaccine (adsorbed) ............................................................. 1998 Dequalinium chloride .....................................)................................................................... 157 Determination of water by distillation (2.............. 2030 Diazoxide ............... 1994 Deferoxamine mesilate................................................................................................... 2063 Dimercaprol .......................... semi-solid preparations for ...34................................................... 1977 Cyproterone acetate................................. 2062 Dimenhydrinate.....42............................................. 8........................5............................... 8....... 2010 Dexamethasone acetate...... 8................................................3–4383 Diclazuril for veterinary use...............9..) .......................................................................................................................... veterinary liquid preparations for.......... 8.................. 1974 Cyclopentolate hydrochloride ............................... 68 Density of solids...................... 22 Dembrexine hydrochloride monohydrate for veterinary use.... 2012 Dexamethasone isonicotinate ..................... 1224 Dapsone ..... 1225 Devil’s claw root .... 8. 17 Determination of aflatoxin B1 in herbal drugs (2...... 185 Deptropine citrate......20......................................) ....... 324 Density....... 110 Detector tubes........1–3743 General Notices (1) apply to all monographs and other texts Index Dexchlorpheniramine maleate...................................6–5275 Dextrose monohydrate...................................................................................................27..................................7–5728 Diethylcarbamazine citrate......2........................................................ 2031 Dibrompropamidine diisetionate .................................6–5248 Dihydrocodeine hydrogen tartrate ................ 2020 Dextran 40 for injection .................31........................................................ 2005 Desmopressin ........................9................. 8......................................................................................... 799 Cutaneous application......) ..............................................................23..............)....N................................................................................ laser light....................................... powders for....................................................6–5250 Diphenoxylate hydrochloride...................... N......... 814 Cutaneous foams .... 2052 Dihydroergocristine mesilate ................... tetanus and hepatitis B (rDNA) vaccine (adsorbed) ..1–3669 Density of powders...................2......) ........ 2040 Dienogest .................8.) ........................................................................................ 2066 Dimeticone .......... 2........... 2024 Dextromethorphan hydrobromide.................................. 2074 Diphtheria and tetanus toxins and toxoids..... 825 Diphtheria...................................................................................................................................................................... 2006 Desogestrel ....................................................................2........................................................ 150 Diethylene glycol monoethyl ether ........................... 3219 Depressor substances (2...... 8..............18. 8................................................ 8..... flocculation value (Lf) of.............4.................... 1051 Cyanocobalamin (58Co) solution ......... gas (2.................. 8................3–4279 Decyl oleate ........................ 2033 Dichlorobenzyl alcohol................................................... 2023 Dextranomer ................................................................................................... 8..................................................... 8..... 1999 Desacyl-4-monophosphoryl lipid A................................................ 1050 Cyanocobalamin (58Co) capsules .............................. 2023 Dextrans..................... gas pycnometric (2............................39....................... 1978 Cysteine hydrochloride monohydrate....... 2043 Diethylene glycol palmitostearate...................................................................................................................... tetanus and pertussis (acellular.........................).............9.... 2046 Digitalis leaf........................................... 2002 Desipramine hydrochloride.. 2065 Dimethylacetamide ..................... 1994 Degree of coloration of liquids (2................................................1–3745 Dichloromethane ...............) ................. reduced antigen(s) content)........... 2044 Diethyl phthalate ............................................................................................................. 2069 Dioscorea oppositifolia rhizome................. 2041 Diethylstilbestrol............ 1975 Cyclophosphamide .........6–5277 Diacerein..........13...............................)...................................................... anhydrous .......................... 1029 Diphtheria.................. 1226 Dexamethasone...... 25 Dental type silica ........................................................... 8...4–4739 Devil’s claw dry extract ......................................... sodium .............4–4735 Dandelion herb with root ...................................... component) vaccine (adsorbed) ............................................................ relative (2................................................. 8.......3–4297 Dioxan and ethylene oxide (2..............9..................................2......47............................. 2034 Diclofenac potassium ..........................EUROPEAN PHARMACOPOEIA 8....................................... 8............30...........................................................................................7.. 2003 Deslanoside .................................................................................................) ............................. ....... 782 Ebastine.......................................8...2–4022 Dwarf pine oil ......... 2083 Disodium phosphate dihydrate............................................................................2..................) (5............... 2129 Effervescent granules . 2112 Droperidol ...................... tetanus..........................................1................ semi-solid .............................1..........................................................................8... reduced antigen(s) content) . 1229 Dry residue of extracts (2....................................... 8.................. 2090 Docetaxel trihydrate ....................... 827 Diphtheria..........................6–5117 Dissolution test for transdermal patches (2..................6............................. 287 Disintegration of tablets and capsules (2....................................................... 2128 Edotreotide (gallium (68Ga)) injection................................................. 2098 Dopexamine dihydrochloride ........42............................................... particle-size (2......... 792 Drops.................................7–5618 Disodium clodronate tetrahydrate ...... 3233 Edetic acid ...) ...................................................7–5617 Eleutherococcus................. recommendations on (5..............................2.................8.......3........ 2129 Emetine hydrochloride pentahydrate .......... pertussis (acellular........ sodium calcium......... 2108 Doxycycline hyclate ......... 2078 Diprophylline ............................................................................. 786 Effervescent powders .... calcium ........1.........2................ pertussis (acellular................................ 2079 Dirithromycin ................1..............6–5252 Doxazosin mesilate.......................................................... 2101 Dosage forms (glossary) ................................................. 781 Ear preparations.......................................... 2130 Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components (3........................................................................ 2084 Disodium phosphate dodecahydrate...........2........ 2094 5862 EUROPEAN PHARMACOPOEIA 8................................... 782 Ear tampons .......................... 2105 Doxepin hydrochloride ....................................6–5173 Edrophonium chloride...... 2087 Dithranol ................47................. 727 Distemper vaccine (live)................................. assay of (2...............................................9....3–4306 Disodium pamidronate pentahydrate .............)...16......... 2734 DL-α-Tocopheryl hydrogen succinate............... 32 Drops (nasal) and sprays (liquid nasal) ........................ tetanus............................ 8........ pertussis (acellular........ 964 Duloxetine hydrochloride...........................................................................). component) and hepatitis B (rDNA) vaccine (adsorbed) .............................. 2078 Dipyridamole ......................) ..................9........8.......... component) vaccine (adsorbed................ tetanus.............................................. 2116 Dutasteride ..........................................................) (5........................... 2113 Droppers (2.. 3442 Dobesilate monohydrate................. reduced antigen content)...............7.......9..............2.9............................................40..............9....................................................... reduced antigen(s) content).................... 2094 Dodecyl gallate.................... 2120 E Ear drops and ear sprays........)............................................. 331 Dissolution test for lipophilic solid dosage forms (2...........47.......8.......9......................................) .....11........ component) and poliomyelitis (inactivated) vaccine (adsorbed.................................................3–4222 Dipivefrine hydrochloride ..................................................................................... 2125 Eclipta herb ......... 811 Dissolution...... 8................................. 2092 Docusate sodium ......)............................................... 2103 DOTATOC (gallium (68Ga)) injection ....... 8.............) ................................40.............. 779 Dosage units............. 8... 8....... 2082 Edetate........................ 8................... 2085 Disopyramide phosphate .......... 276 Duck plague vaccine (live)............... 962 Distillation range (2........................................................ 285 Disintegration of tablets and capsules (2................. tetanus............................... 1230 Dydrogesterone....1–3734 See the information section on general monographs (cover pages) ........) ..................................................... 8.....................................).....................................).............................. 8................................... 840 Diphtheria......................... 2099 Dorzolamide hydrochloride ..9............... canine...........47. 8.. 2086 Dispersible tablets....... intrinsic (2...17................ 15 Drop point (2......... 2956 Disodium phosphate...................................................... pertussis (acellular............. demonstration of uniformity using large sample sizes (2............... 2126 Econazole nitrate ..... 361 Dissolution...........................................38................1............ 79 Electrophoresis.......................) ...............1...............................9....7–5459 Electrophoresis.................... component)...) .... 782 Ear powders..).............................9............. capillary (2........7–5620 Disulfiram...............................43... 2097 Dopamine hydrochloride . 782 Ear washes ................... 8.......)..... 834 Diphtheria................ 837 Diphtheria..................... 1231 Econazole..........................31................................................................) .........................................2–3951 Diphtheria...............4...............)............. apparent (2.... 8................. 782 Ear sprays and ear drops........................ uniformity of (2............Index Diphtheria... pertussis (whole cell)............................................................................................................2...........................) ......... disodium . reduced antigen(s) content)............... 782 Ear preparations.17.......................... 835 Diphtheria......................................................................................5–4887 Distribution estimation by analytical sieving.. 2075 Dipotassium clorazepate....................... 8........................7 Dog rose. 8................................. 8.... 963 Duck viral hepatitis type I vaccine (live) ........... tetanus......... 8............................ 8.......... 844 Diphtheria vaccine (adsorbed)..............8.............. tetanus.......).......................... 361 Dissolution test for solid dosage forms (2... capillary (2...... 8..................... 8.......................)...... particle-size (2.).............................................1–3669 Dosage units............... 2106 Doxorubicin hydrochloride............................ 832 Diphtheria.. component) and poliomyelitis (inactivated) vaccine (adsorbed).............................................................................................................) ..........3.................................................................................................................. 1234 Emedastine difumarate ........) (5.......29..................................... 237 Diphtheria vaccine (adsorbed....................................................................... 295 Dissolution testing................... 2089 Docetaxel.. 8.. 2095 Domperidone maleate............................................7–5619 Dissolution test for solid dosage forms (2..................... 2081 Disintegration of suppositories and pessaries (2.........8............................... tetanus..............................................7–5736 Doxylamine hydrogen succinate...............................................2.....................2...... poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) ...............).. 800 Effervescent tablets.................... tetanus and poliomyelitis (inactivated) vaccine (adsorbed..........................................................) (5........ 8.... 8....... 830 Diphtheria......................................4........... 1049 Edetate.......... pertussis (whole cell) and poliomyelitis (inactivated) vaccine (adsorbed) ......9............................. tetanus and pertussis (acellular........................ 2082 Disodium etidronate ..................................7–5617 Electrophoresis (2..................6–5173 Doxapram hydrochloride .6–5123 Dosulepin hydrochloride.... evaluation of (5................................................................ pertussis (acellular......................................... component) and haemophilus type b conjugate vaccine (adsorbed) ..........2.................... 351 Distribution estimation by analytical sieving........... 1919 Disodium edetate..... 791 Drospirenone ....................... 2127 Edetate (chromium (51Cr)) injection....9.....................................3...........................).............. 947 Distemper vaccine (live) for mustelids ..... 8...4–4743 Dry extracts ............................7–5734 Doxycycline monohydrate.................... 8............ 1232 Electrophoresis (2...) (5................... 846 Diphtheria vaccine (adsorbed).................9.....)..7–5620 Dosage units................................. 591 Egg drop syndrome 76 vaccine (inactivated) ....................)...... anhydrous................... 557 Efficacy of veterinary vaccines and immunosera...................... hepatitis B (rDNA)...................................9..... 1733 Dobutamine hydrochloride ..................... poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) .......... 829 Diphtheria..) .................... 811 Efficacy of antimicrobial preservation (5............. anhydrous.......................................................5–4917 Drynaria rhizome .....31.................................. 842 Diphtheria........................ poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) .............6–5251 DL-Methionine .................. 2077 Dipotassium phosphate ................... tetanus and pertussis (whole cell) vaccine (adsorbed) ............................. 2084 Disopyramide.....................38... pertussis (acellular..........................) (5............................................................................................................................. 1228 Domperidone ..................... component)................................................................................................................................. tetanus...................................................9........................ oral....................... 965 Elder flower ............................ uniformity of (2.......................7.............. 417 Emulsifying cetostearyl alcohol (type A). ........ 2178 Ethacridine lactate monohydrate...................................................................... 783 Eye lotions .......................................................10......................................... residue on evaporation (2............)......................... solutions and suspensions.....8......................................... 790 Enalaprilat dihydrate.........................3–4304 Ethosuximide .............8............................... 2186 Ethionamide ......... 271 Essential oils in herbal drugs (2.....................17................................................. 8.......................).........................6...................) ........................................ 8................................................................) ............... swine.. 571 Extracts. infectious.............. 2193 Ethylene oxide and dioxan (2................................................................................................ 8................................ 8.................9.................................................... 155 Estradiol benzoate .... 272 Essential oils....................................................... 2201 Etoposide ...................7–5633 Extractable volume of parenteral preparations.........................................................................................4–4497 Ethylhexanoic acid..... 2194 Ethyl oleate ..........) . 8............. 2206 Excipients...............................) ....... 8............... 2191 Ethyl parahydroxybenzoate sodium... 2146 Ergoloid mesilates........... 1491 Epirubicin hydrochloride ................. 198 Extraneous agents : tests in batches of finished product of avian live virus vaccines (2......................5................................................................................. 8....................... 2154 Erythromycin ethylsuccinate............ 2197 Etofenamate.........................6.....5... porcine.................................... 2............ solubility in alcohol (2................................. 276 Extracts..................... 2134 Enoxaparin sodium ........................ 2728 Ethylcellulose................. 2158 Erythromycin stearate.16...............................).............. 968 Equisetum stem .......) ............................................................) .....) ..........................................................5–4911 Extracts........................9. 1265 European viper venom antiserum ........................28.30.................................................................... 8.......................................... 2190 Ethyl acrylate ......................................8.....................................8.. 8............................... 2136 Enrofloxacin for veterinary use....... 2169 Estradiol hemihydrate.........................................) . 271 Ester value (2......... 908 Encephalomyelitis vaccine (live)...................................................... 1944 Ergometrine maleate .............. 8............... 2141 Ephedrine hydrochloride................................. soft. 2185 Ether.........23........................................................................................................................................................................................................ 3558 Extraneous agents in viral vaccines for human use. 8.........4–4505 Extraneous agents : tests in seed lots of avian viral vaccines (2..........17... oral ...5–4917 Extracts.....................9.................................... 2193 Ethylene glycol monostearate......methacrylic acid copolymer (1:1).........................................................................) ......................10........................................................................... anhydrous (5......14............... 572 Enilconazole for veterinary use ......... 2142 Ephedrine hydrochloride.................................................. herbal drug ...........................24............ 8...................) ............................. test for (2..................................................... 1018 Erythritol ............................................................................4.............. 150 Ethylene glycol monopalmitostearate ........ 150 Ethyl acetate ......................2.....6–5257 Extemporaneous preparation of radiopharmaceuticals (5........................................ 2205 European goldenrod..... 8.. 8......... functionality-related characteristics of (5...........................................19.................................. 591 Evaluation of safety of each batch of immunosera for veterinary use (5.... odour and taste (2...................................7–5623 Ethanol (96 per cent)...................2–4027 Esomeprazole magnesium trihydrate................... 2193 Ethylene glycol and diethylene glycol in ethoxylated substances (2................................................................................5–4899 Ether ................................................... 8.... 2131 Encephalitis vaccine (inactivated). 2179 Ethambutol hydrochloride .............................. foreign esters in (2............................. 2149 Erysipelas vaccine (inactivated).........15...........................................11..................................... dry residue of (2........................................10..........) .............8.................................................16........) .................... 2199 Etomidate..7..4..................... 784 5863 ................ 2180 Ethanol (96 per cent) (5............ fatty oils and resinified essential oils in (2.......... 194 Endotoxins........................................... bacterial (2........................... 604 Evaluation of safety of veterinary vaccines and immunosera (5..... 2177 Etamsylate...................................... 2174 Etacrynic acid.....................EUROPEAN PHARMACOPOEIA 8..... water in (2....................8............................................................................................. 8...........2................. 2133 Enalapril maleate .............................. 2151 Erythromycin estolate .........................1–3735 Emulsions......25............... 2148 Ergotamine tartrate ...... loss on drying of (2...................................8................ 1237 Ergocalciferol ..................................................................................... 8...........................................................) ................................. 1236 Ephedrine......... 272 Essential oils.................)..... 3243 Etidronate disodium.....................................5–4917 Extracts used in the preparation of herbal medicinal products for oral use....................................) ...............................................................8.......... 8.............................. 222 Extracts used in the preparation of herbal medicinal products for oral use..........) .....................) ...............6.................... 271 Essential oils.......................... 783 Eye preparations ..2–3965 Eucalyptus oil ........ 272 Essential oils..8.......................) ...... conjugated.........................6.......... 8.....................4....................6. water for preparation of...25........................................................... anhydrous .... 1490 Epinephrine tartrate .................................. 8............................ 2727 Ethyl acrylate .......9.................................................1.)............... tick-borne............4–4750 Eserine salicylate.......................................................... 2173 Estrogens............................................. 273 Essential oils....... 8...... 967 Equine influenza vaccine (inactivated) ........................5–4916 Extracts.. microbiological examination (2.8... 276 Extracts....................... ethylene glycol and diethylene glycol in (2.................................... 8..... 588 Evening primrose oil...5–4979 Ethanol content (2....8................................................................ dry ......3–4343 Equine herpesvirus vaccine (inactivated).............5–4977 Ethanol..methacrylic acid copolymer (1:1) dispersion 30 per cent ....................................................8................... 931 Endotoxins...... 8.......... 148 Ethylmorphine hydrochloride..................................................... 2190 Ethyl parahydroxybenzoate ................................... assay of 1.................................... anhydrous. anaesthetic.........................................) ...............) ...........................) ..........12............................4............................. 2140 Ephedrine hemihydrate ............. 2156 Erythromycin lactobionate ..................................................................... 2185 General Notices (1) apply to all monographs and other texts Index Ethinylestradiol ..............8................. 8.............................. 2196 Etodolac .......................... 2145 Eplerenone................................5–4917 Extracts..........................30.................... 2192 Ethylcellulose (5...) .................. 8. liquid (fluid) ...............................17..................8........................... semi-solid ... 2139 Entecavir monohydrate. test for (2............................................. 2143 Epinastine hydrochloride...............................(2.......................)........................) ...........................................................) (5............................) ............. tests for (2..........................................................8................................................2–4028 Essential oils ................... 2150 Erythromycin ............................7–5742 Estriol ........ microbiological quality (5...... 8.......... 3027 Esketamine hydrochloride................. 2137 Entacapone ....... 8.....2................).......... 1033 Evaluation of efficacy of veterinary vaccines and immunosera (5................ 1240 Eugenol ....................................1.... 8............ 782 Eye preparations..8-cineole in (2...........................................................1–3659 Eye drops ..........................7–5623 Ethanol............... racemic ...6.. 2166 Esomeprazole magnesium dihydrate ........................................ 2171 Estradiol valerate ........... 743 Essential oils..................3–4306 Etilefrine hydrochloride.........................................................4–4749 Eptacog alfa (activated) concentrated solution................................................... herbal drug......................................... 8.)...........) .............................................. 1001 Ephedra herb .......................) ..................2................ 2160 Erythropoietin concentrated solution......................... monographs on (information chapter) (5.... 719 Exemestane....................................................................) ............... 2188 Ethoxylated substances...... 1239 Eucommia bark.... avian ......................9............................. refined.................................... bacterial.............7 Emulsifying cetostearyl alcohol (type B) ........................................................ 272 Essential oils........................................................................................7–5620 Extracts................................................................................................31..... 8........8............ guidelines for using the test for (5.......................7–5623 Ethylenediamine ......................6....1–3749 Enoxolone ..............3–4306 Eucalyptus leaf ............................... 308 Extractable volume of parenteral preparations.....................................................................7...................................7–5741 Enzootic pneumonia vaccine (inactivated)..................... 2144 Epinephrine .......... ....... 139 Fatty oils..............2–4033 Fenugreek .................) .7.................7... 8..... 136 Formaldehyde.............. assay of (2.......................) ...... sweet .. 133 Fatty oils and resinified essential oils in essential oils (2...... 2278 Fluvastatin sodium ...................... 758 Ferric chloride hexahydrate.......................... human coagulation ... 2213 Feline calicivirosis vaccine (inactivated).................................................................................................... 8..... 1244 Fermentation....1–3757 Fleeceflower root... 1055 Fluorides (2............. 800 Felbinac ............................................................ 1244 Fexofenadine hydrochloride......4..).......................5..4.... composition of (2........................4............... 2219 Fenoterol hydrobromide .......................... 8........ human coagulation...................... 2266 Fluphenazine decanoate..............................)........... 8.................. composition by gas chromatography (2. 2274 Flutamide.... 1242 Fenofibrate.................... medicated ..... 8................................................................................................................ 271 Fatty oils..................................... 8............................................... 1045 Flubendazole ...........7...... 974 Feline leukaemia vaccine (inactivated) ............................................... 2272 Flurbiprofen.......... assay of (2.............. 2248 Fludeoxyglucose (18F) injection ........................................ 2386 Fatty acids...........16.............................................. 8.... 1058 Foams..............) .......................21...............................................3–4314 Filgrastim concentrated solution........ 1734 Follitropin .......).............................................................. 8......................................................... 2271 Flurazepam monohydrochloride ...................................... 2275 Fluticasone propionate.. 2217 Fenbufen ........ dried.......................................................6–5286 Factor VIIa (rDNA) concentrated solution.......................)................................ human coagulation .............................................................................10.......................4........................... 2243 Fluconazole.....................)..........................2.................... human coagulation................................................................. 2223 Fenticonazole nitrate ............... intrauterine .....................................5–4935 Fluoromisonidazole (18F) injection..... 2281 FMISO (18F) injection ................................................. 248 Factor IX (rDNA) concentrated solution............. 977 Felodipine ...................................................21...................................................1–3697 Feline panleucopenia vaccine (inactivated).................... premixes for.3.)............. 2273 Fluspirilene ....................................................................................................... 2259 Fluorescein ............... 775 Fc function of immunoglobulin......................49.......................... vaginal.........................2–3929 Factor VIII (rDNA)..... 1045 Fluorodopa (18F) (prepared by electrophilic substitution) injection ...........8......................................... 2418 Fibrin sealant kit ............. 35 Fluorodeoxythymidine (18F) injection ................... 8........................................ 2260 Fluorescein sodium ....................................................... 8......................... 2250 Flumazenil ..................................................................................................................... 2215 Fenbendazole for veterinary use.......7.......................................5–4935 Feverfew .... 8. cutaneous ...................4–4757 Fluocortolone pivalate..9............................................................................................................................. 2241 Flucloxacillin magnesium octahydrate ...................................................................................)...................... 2416 Factor IX................................... 2268 Fluphenazine dihydrochloride ..............)....... 2251 Flumazenil (N-[11C]methyl) injection.........................) ..........4.................................. 2211 Fat.......6–5099 Fatty acids in oils rich in omega-3 acids.................... assay of (2................................................ 85 Famotidine.......................... 2283 Folinate................... 1056 Fluoroethyl-L-tyrosine (18F) injection ................................................) .........11..................................22......... 247 Factor VIII......... sterols in (2................................18.......... human coagulation ........................................35................................................................) .................................................27.................................... 8.........2–3957 Fludrocortisone acetate..................................... 136 Fatty oils.................... 973 Feline panleucopenia vaccine (live) ......... 8....... assay of (2............................... 2226 Ferrous gluconate .) ....................................2.........................................) ......7–5760 Factor XI.. application of (5...........................................) ..............................................................................................22................................... 8..................................5–4896 Factor IX............. 122 Fatty oils...............19............ 971 Feline chlamydiosis vaccine (inactivated) .............. 8......... 970 Feline calicivirosis vaccine (live)..... identification by thin-layer chromatography (2.... alkaline impurities in (2. 8............. 2254 Flunarizine dihydrochloride............................................................ 2253 Flumetasone pivalate... medicated...........4.... 8............................... 807 Foams....................................................... human coagulation ...... 813 Folic acid...................................9.....................8. 2235 Fineness..................................................... human coagulation.............................................................................) .....).................. 2408 Factor VII.......................Index F F0 concept to steam sterilisation of aqueous preparations...............................) ...................................... 2238 Flecainide acetate................... 2212 Feeding stuffs for veterinary use............... 2242 Flucloxacillin sodium ........................................................................................................................ 784 Foams..... hard .... 8.................................................................................................................2.........................6..... human coagulation ...................... 8...................) ...... 346 Fish oil................21................................................ 8...............................7..8...........................................................................................................7.........5................................................ 132 See the information section on general monographs (cover pages) .................18.................................................... foreign oils in.............................................................................................. 2415 Factor X....6–5265 Flutrimazole .. free (2.................. 796 Finasteride ................................................ calcium...............................................................6–5101 Fatty oils................. human coagulation..........3–4231 Foreign esters in essential oils (2........................... 128 Fluorimetry (2.........) .............. powder (2........................ 560 Factor II.......................... human coagulation....... human coagulation....................................... 2255 Flunitrazepam . vegetable................. 8......................... test for (2........................................................................3–4321 Foot-and-mouth disease (ruminants) vaccine (inactivated) ...... 2227 Ferrous sulfate.......................... 246 Febantel for veterinary use .............................2–3930 Falling ball viscometer method (2..... 1054 Flumequine............................. 259 FLT (18F) injection ............................................................ 8................................................................................. 2229 Ferrum metallicum for homoeopathic preparations.....23......................................................................... products of . 790 Foams....) ............... 2269 Fluphenazine enantate ......................7...................................................................... 972 Feline infectious enteritis (feline panleucopenia) vaccine (inactivated) .............. 8........... rich in omega-3 acids ..........................29..................................... 1245 Flocculation value (Lf) of diphtheria and tetanus toxins and toxoids (Ramon assay) (2............................................ 2225 Ferrous fumarate..... 2264 Flupentixol dihydrochloride................1....4............ 2220 Fentanyl.................... 261 Flowability (2..............................3–4313 5864 EUROPEAN PHARMACOPOEIA 8.... 2257 Fluocinolone acetonide....................... orodispersible ............................................... 974 Feline viral rhinotracheitis vaccine (inactivated) ...................................... 8.....................................24............. 8.......3–4343 Factor VII............ by thin-layer chromatography (2.............................................................. bitter ....................................................... 2214 Felypressin ............ 2245 Flucytosine.... 976 Feline viral rhinotracheitis vaccine (live) .....9......... assay of (2.........4.......2.......... assay of (2........................6–5263 Fludarabine phosphate..................................................................................................... rectal ...................... human coagulation...........................................................7 Fibrinogen...........1–3665 Foreign oils in fatty oils by thin-layer chromatography (2..7.............................................. 787 Foams.........19................ human coagulation ..............) ............................................ 2236 Flavoxate hydrochloride........) ............................................................ 271 Foreign matter (2................. 307 Flow cytometry (2............................6–5261 Films..............3–4316 Follitropin concentrated solution .............................)............................................................................................ 2256 Flunixin meglumine for veterinary use ......................................................................7–5747 Fentanyl citrate..........7................... 973 Feline infectious enteritis (feline panleucopenia) vaccine (live) ...7..... 1058 Fluorouracil .. 2262 Fluoride (18F) solution for radiolabelling. 255 Factor XI.......... 1241 Fennel................. 2228 Ferrous sulfate heptahydrate ...................................................................................4..................... 2279 Fluvoxamine maleate................................................................................................. human ...2–3989 FET (18F) injection........ 8.. 2263 Fluoxetine hydrochloride... 2218 Fennel................................................................................................................... 2414 Factor VIII. .................................................................. for veterinary use... 1736 Glucosamine hydrochloride ... 719 Furosemide ..................................................).................................5–4917 Glucagon............................... 8.. 2310 G Gabapentin ............. 161 Gases...4......................................5.................... 1032 Gas pycnometric density of solids (2....6–5278 Grafted copolymer............. 8............ 2354 Glycerol monostearate 40-55 .........7........ 794 Ginkgo dry extract.............. 1259 Ginseng .....3–4331 Gels....................................................8.............) (5........4–4759 Foscarnet sodium hexahydrate ............ 163 Gas-gangrene antitoxin.........................1..................................................................................) ............).............. 8..................................... 8................................................................. 579 General texts on microbiology (5........................................ 780 Gastro-resistant granules .. 2321 Gargles ............................................................................................1.....................4–4525 Glibenclamide ........................................ 2326 Gentian root ........ 100 Glycerol......................................................................... anhydrous ......2. human .......... 8........1–3706 Goldenrod...........................)........ friability of (2.... anhydrous (5...... 555 Gene transfer medicinal products for human use (5..................... oil-adjuvanted.. 1266 Gonadorelin acetate..... 2341 Glucose...................6–5188 Ginseng dry extract ........................................... 163 Gases... 8.. injectable) for salmonids.......... 8..................................................18........................... standardised ................................... 786 Greater celandine...................9.........3–4240 Free formaldehyde (2...........................................7–5620 Gas chromatography (2...................) .................... 2337 Glucoheptonate..................... 1060 Gallium (68Ga) DOTATOC injection ..... 779 Glossary (herbal drug extracts) ....................... glycan analysis of (2........ 2360 Gonadotrophin..... 8......................................................................... 8........................................... 2317 Gadobutrol monohydrate ......) ...................5.........2............................................... 1265 Goldenseal rhizome.....41............. 8................ 359 Friability of uncoated tablets (2....................................................)..................... 811 Gefitinib ............. 8......................................................................................6–5268 Fumitory ..........................7–5624 Glucose monohydrate ........ 8.................28............... 786 Granules..........6–5277 Glutamic acid . 8......................7–5751 Galactose... 2342 Glucose monohydrate (5..................................................................9................18............. 791 Granules and spheroids.... 2362 Goserelin.... 100 Glycopyrronium bromide................................ 8..6.................. 2319 Gallium (67Ga) citrate injection ....)............. 163 Gases..... Indian...................................6–5275 Glucose............... liquid ..............26............. 8.. 2301 Fosinopril sodium ........................ 34 Fresh bilberry fruit dry extract................... 2358 Glycyrrhizate ammonium.............................................................................................................................. 2353 Glycerol mono-oleate ................................EUROPEAN PHARMACOPOEIA 8........... 2344 Glutathione............ refined and standardised ..........................................26..) .................... 2361 Gonadotrophin...........) (5.................23................ 8.....2–3981 Garlic powder.....6–5186 Friability of granules and spheroids (2........ 2349 Glycerol distearate .3–4333 Glucosamine sulfate sodium chloride.............................................. nitrous oxide in (2....... 8......................................................................................7............7–5753 Glycine ....... 3245 Fusidic acid......................) ................................... 1255 Gestodene ..................................................9.........................................) .............. 2297 Fosfomycin calcium........ 8.........5–4949 Gentian tincture.........)...................................3–4232 Fusidate............... 2328 Ginger ..............9... 2338 Glucosamine sulfate potassium chloride .................................... identification reactions of (2....................... 162 Gases......................................)...........................).............................6–5173 Gallium (68Ga) edotreotide injection ...................................................... 132 Freezing point (2......................................... 359 Granules.........2........ 1552 Goldenrod..............) .................................... 8................................... 1060 Gallium (68Ga) chloride solution for radiolabelling ......................................................................................... oxygen in (2..........................................7–5752 Gelatin (5...........6–5267 Fucus .......................................... 1276 Fraxinus rhynchophylla bark ...................................... 2351 Glycerol monocaprylate........................................................ 2351 Glycerol monocaprylocaprate .14.........1....7–5623 Gelatin.........................................................................................5–4984 Glycoproteins........................................................................ carbon dioxide in (2.............................8.............................................................) .... mixed ...................................................................... 1030 Gas-gangrene antitoxin (novyi) ........................ 8......................5.....8.... 8............ 791 Granules and powders for syrups ... refined and quantified ..............................) .......................................) ........................................... 1247 Frangula bark dry extract........................ 2346 Glycerol (85 per cent) .............. gastro-resistant ................................. 119 Functionality-related characteristics of excipients (5........26.....................8.... carbon monoxide in (2................. 1257 Ginkgo leaf .7–5620 Fructose........ liquid.......................................................2.............................................................. 980 Fowl-pox vaccine (live) .........................................................................................................................................4–4693 Gemcitabine hydrochloride........................... specific surface area by (2.. 705 Gentamicin sulfate............... 8....................................)....................... water in (2.........6–5173 Ganciclovir ........................... 2339 Glucose............................. 8.............) ...........................................................................5..... 2302 Fourstamen stephania root...................................................................................................................................5–4948 Functional groups and ions.......................) .2–3897 General texts on biological products (5...... 8............... 2299 Fosfomycin sodium ...................................... 1262 Glass containers for pharmaceutical use (3.........................................) .............) .........9........6–5273 Glipizide................................................................................. 8........................... 2348 Glycerol dibehenate.............. nitrogen monoxide and nitrogen dioxide in (2.................................... 8..................................................................... 2300 Fosfomycin trometamol........................................................................... 8.......................................................................................................................................... 168 Gases......................... 2352 Glycerol monolinoleate.................................5........................28.............. chorionic......2.. 786 Granules................................................. 1256 Gingival solutions ............... 786 Granules.................................) ........................ 8.... 808 General Notices (1) apply to all monographs and other texts Index Gels for injections........... 2350 Glycerol formal .. 8................................................ 1246 Fowl cholera vaccine (inactivated) ......)............................................... 1286 Fulvestrant .................... 8....................................... 324 Gastro-resistant capsules ......................... 43 Gas detector tubes (2....................... 2335 Glossary (dosage forms) ....... 2325 General notices (1.................................................. 8................................... 794 Garlic for homoeopathic preparations..........................................5–4947 Frankincense........ 2295 Formoterol fumarate dihydrate................ 2332 Glimepiride ................................................................................................................... 8...9.... 8...3–4332 Gemfibrozil.................) ...............) ............................................................................................................... 2330 Gliclazide .....................................2.............................................. 1031 Gas-gangrene antitoxin (septicum)... European.... calcium ................. spray-dried ................... 2355 Glycerol triacetate.................................................................................7 Formaldehyde solution (35 per cent) ............................. 329 Gas adsorption................................................................... 298 Friability of uncoated tablets (2.....................................................25........59..............41...............) ..........................................59............ 2660 Gramicidin ................................................ modified-release................ 2366 Granules..............1......... 2305 Frangula bark . coated .... specific surface area by (2...............................3... 3459 Glyceryl trinitrate solution ....................... effervescent ................... 1254 Gas adsorption.................... 8.................... 8...9.............................. 1268 5865 .................................................................................... sodium.....................................................................................27...............................................................5–4983 Glycan analysis of glycoproteins (2................................ 8...............................................................5.......) . 2365 Granisetron hydrochloride........................................................................................35..................... equine serum..........15........................24.... 785 Granules and powders for oral solutions and suspensions............................................................................. 1030 Gas-gangrene antitoxin (perfringens)...........................................................................................................7–5624 Glucose... macrogol poly(vinyl alcohol) ............. 17 Gases....8........ 981 Framycetin sulfate ....... 786 Gastro-resistant tablets .......6–5273 Galantamine hydrobromide .......3–4327 Furunculosis vaccine (inactivated............. 8............................................................ ............6–5190 Hamamelis leaf...................... 8... low-molecular-mass ..................23.......3–4264 Homoeopathic preparations.................) ....................... heavy metals in (2.. assay of (2..................................................... Apis for.................................................... 746 Herbal teas..... adsorbed) and typhoid polysaccharide vaccine ............................................... 902 Hexamidine diisetionate ..................... 1441 Homoeopathic preparations................. microbiological examination (2.........................................................Index Griseofulvin............................................. 8............ 8............20.............. 8. human .. poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed)...7 Hepatitis A vaccine (inactivated....... 249 Heparins..... 8.. 8........................3–4187 Heparin calcium ... cadmium sulfuricum for .... assay of (2...................21) ............................................27... 8.....5–4915 Herbal drug extracts. determination of aflatoxin B1 in (2.... 2370 Guanethidine monosulfate ...).... 747 Herbal teas.............................. pharmacopoeial (5........................3–4263 Homoeopathic preparations............................................. 8......... numeration of CD34/CD45+ cells in (2...................5–4911 Herbal drug preparations ........................................... viral........... tetanus...................... duck ....4............................... 1429 Herbal drugs.............................. concentrated solutions for ....... rabbit....... microbiological quality (5........5–4921 Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine (adsorbed) .... 8......... component)... 830 Haemophilus type b (conjugate)........ 2375 Haemodialysis....................20......... diphtheria.................).............3–4341 Hepatitis A immunoglobulin..........................................................................................3–4264 Homoeopathic pillules. 1270 Hard capsules ........ pertussis (whole cell) and poliomyelitis (inactivated) vaccine (adsorbed) ................ pertussis (acellular.... 273 Herbal drugs for homoeopathic preparations...................... 8...... 279 Herbal medicinal products for oral use and extracts used in their preparation...............................2–3921 Hepatitis type I vaccine (live).. diphtheria............... diphtheria and tetanus vaccine (adsorbed) ..... 1448 Helium .................................5–4923 Hepatitis A vaccine (inactivated.....)......... 1271 Hawthorn leaf and flower ....................... tetanus and pertussis (acellular.........14..................... diphtheria....... 8...5–4924 Hepatitis B immunoglobulin for intravenous administration.......... 837 Hepatitis B vaccine (rDNA) ...................2–3985 Homoeopathic preparations.... diphtheria.... 8....................... 746 Herbal drugs......... 2387 Heparin......... tetanus............................................... anti-A and anti-B (2....7........) ....... instant........... 2565 Heavy magnesium carbonate .......8...... solutions for ............................... 837 Haemophilus type b (conjugate)...................................................... colony-forming cell assay for (2.................... 8................................6–5206 Homoeopathic preparations..............) .......... 8.......................................2–3984 Homoeopathic preparations..... 571 Herbal preparations........ solutions for............................................)...........................................................2–3981 Homoeopathic preparations.............................................)......................... 2402 Homoeopathic pillules......................... human ....7–5617 Hawthorn berries... 2392 Heparin sodium ....................)....................6–5283 Highly purified water . 2401 Homatropine methylbromide ...................... 2386 Hard paraffin.....2–3981 Homoeopathic preparations......................................................10....) .................................. 2378 Haemophilus type b and meningococcal group C conjugate vaccine ........................................................ 840 Haemophilus type b (conjugate)......................................... 8..............................................20........... 278 Herbal drugs........ 8..........................................18.......................................... 8.7–5758 Hexetidine ...... 8......9..................................................... component) vaccine (adsorbed)............. coated........................6............7................... 184 Histamine dihydrochloride ..... 964 Heptaminol hydrochloride ......................... 2381 Haloperidol.......................................................................................8.....................1............... diphtheria................................................... barium chloratum for........ 8........... 3559 High-molecular-mass macrogols............ 8... 8............................................. 8........................2–3911 Hedera helix for homoeopathic preparations .......................................................5...... 252 Hepatitis C virus (HCV)... 8.................. 282 Herbal drugs : sampling and sample preparation (2. component).............) ...............................7–5700 Histaminum for homoeopathic preparations ............................ 8...... 832 Hepatitis B (rDNA)................... virosome) .......................8......... calcium iodatum for ......... 844 Haemophilus type b conjugate vaccine..... essential oils in (2....3–4349 Hepatitis B immunoglobulin..................... arsenicum album for ... 8............................................. 203 Haematopoietic products..........................12... 8.............. 8..... assay of (2..7................. human.................................... 2396 Hexosamines in polysaccharide vaccines (2.... 8........................ 2394 Herbal drug extracts................................. assay of (2... 2382 Haloperidol decanoate ..........................6...................... 2670 Heavy magnesium oxide................................................ pertussis (acellular........................ 1273 Hawthorn leaf and flower liquid extract....................)..................... tannins in (2.............................) ................................................... 1274 Heavy bismuth subnitrate.............................................. 857 Hepatitis B vaccine (rDNA)........................................... microscopic examination of (2............ monographs on (information chapter) (5.........3–4348 Hepatitis B (rDNA).............. 8...............4........................................... 1007 Halofantrine hydrochloride... 222 Herbal medicinal products for oral use and extracts used in their preparation............. 2398 Histamine for homoeopathic preparations ..... 2371 Guar......... concentrated......................................................... 2677 Heavy metals (2......27........2–3985 See the information section on general monographs (cover pages) . Allium sativum for .............................. 8.......... impregnated ....................) .................) ..........................................................7.................28.......................................2–3911 Herbal drugs..1.).......8.......... test for aristolochic acids in (2.... adsorbed)..................................................10... solutions for................................ 1272 Hawthorn leaf and flower dry extract ......... 262 Haematopoietic stem cells.....4.......8.........................7........ 572 H Haemagglutinins..........................................................................7–5700 Histidine .23................................ 746 Herbal substances ................ 2368 Guaifenesin. 160 Hexylresorcinol ...........4–4763 Haemofiltration and haemodiafiltration.... component) and poliomyelitis (inactivated) vaccine (adsorbed) .................. 825 Hepatitis B (rDNA). 780 Hard fat ......... 572 Guidelines for using the test for sterility (5............................... 8.......... 746 Herbal drugs and herbal drug preparations..................................... 2367 Guaiacol ........ pertussis (acellular........8.................... 2378 Haemodialysis.... aurum chloratum natronatum for ............... diphtheria....... Belladonna for.....) ..15. 8.......... 8.........2–3983 Homoeopathic preparations........... equine.............. validation of nucleic acid amplification techniques for the detection of HCV RNA in plasma pools : guidelines ............................................. 8... tetanus... tetanus and pertussis (acellular................. 1676 Heavy kaolin................6............................ Agaricus phalloides for ...................23)......................................... 258 Haematopoietic progenitor cells..................... 275 Herbal drugs................... water for diluting....................... 8. 2371 Guidelines for using the test for bacterial endotoxins (5..........12.........) .............................1.......8.3–4375 Histamine (2.....)...2–3983 Homoeopathic preparations....3–4348 Hepatitis A (inactivated. component) vaccine (adsorbed)............................................................................ Anacardium for.......................................... quantified ........ 2419 Haemodiafiltration and haemofiltration....... 967 Herpes zoster (shingles) vaccine (live)...5–4922 Hepatitis A vaccine................... human....7–5665 Haemophilus type b (conjugate).........31............3–4339 Heparin in coagulation factors..........4–4763 Haemodialysis solutions...............8...6–5109 5866 EUROPEAN PHARMACOPOEIA 8..2–4041 Histidine hydrochloride monohydrate ..................... 8..7–5757 Hamamelis bark............... 8............................... 8.......................... 8....................................................2–4042 Homatropine hydrobromide ........ tetanus.......................................................................................... hepatitis B (rDNA) and poliomyelitis (inactivated) vaccine (adsorbed) ............... 8........................ 748 Herpesvirus vaccine (inactivated)..............) ...................7.............14........................................ human..................).. 8.....5......................... 2383 Halothane ............... 8.......) ........7–5666 Haemorrhagic disease vaccine (inactivated).........2–3984 Homoeopathic preparations.............................................................................. 128 Heavy metals in herbal drugs and herbal drug preparations (2.. 2964 Harmonisation................ 276 Herbal drugs... 1269 Guar galactomannan ....................8................ ..................................) ...................................................................................7...........7......................... 2436 Hydralazine hydrochloride................................................................ 3289 Hydrogenated vegetable oils..31...................... 8...................................................) ..............................................7........ assay of (2...........7–5625 Hydroxypropylmethylcellulose ...)............................................... 8.........7...................................................... assay of (2... 8...... 8.........7.7–5625 Hydroxypropylcellulose......................... 2453 Hydroxyethylcellulose ..........3–4357 Human varicella immunoglobulin ...................... 8.................) ........) .....................8........ 8.......................7.... 2460 Hyoscine ...........28..... assay of (2................. 8...............................6–5197 Honey ....... mother tinctures for ...2–3983 Hop strobile..........4................................................ 1451 Hypromellose (5............. 8........................7................. 1449 Homoeopathic preparations.......................................... 8............ 2428 Human α-1-proteinase inhibitor.................................... 2425 Human plasma (pooled and treated for virus inactivation) ....2–3990 Homoeopathic preparations. 2434 Human von Willebrand factor .......... 2473 5867 ....................... Crocus for ........10.......................... 2446 Hydrogenated arachis oil ...............5–4896 Human coagulation factor IX .............................6–5291 Hydroxypropylmethylcellulose phthalate ......) ................................................. 8.... 2452 Hydroxycarbamide ............ 2408 Human coagulation factor VIIa (rDNA) concentrated solution .............19...... 8.... sodium...... 1391 Hypericum for homoeopathic preparations....................... assay of (2..7..7–5479 Human coagulation factor II................................................................... Urtica dioica for ................. 1782 Hydrogenated cottonseed oil.............3–4353 Human plasmin inhibitor................... 1448 Homoeopathic preparations....................... 8........................................... dilute .......................25...................... magnesium phosphoricum for .......................................................8............. 2423 Human normal immunoglobulin for subcutaneous administration..... 8.17..............................................................................1–3715 Homoeopathic preparations............... 2461 Hyoscine butylbromide..............................................7.......... low-substituted ..............).............................. 8..................................................................... 2745 Hydroxyethyl salicylate ................ 8..........4–4765 Hydrastis canadensis for homoeopathic preparations ................... 2429 Human rabies immunoglobulin . 257 Hyaluronate................11...............4..... 2464 Hyoscyamine sulfate.............. 8.. 2414 Human coagulation factor VIII. 2415 Human coagulation factor X................ 2435 Human von Willebrand factor.............. hypericum for..............3–4348 Human hepatitis B immunoglobulin for intravenous administration...............) ......................................................... 2450 Hydroxocobalamin chloride............. 1064 Human albumin solution .................................... 2416 Human coagulation factor IX.................................. 2448 Hydrogen peroxide solution (3 per cent) ............ 8.......................................................................3–4270 Homoeopathic preparations............ 2451 Hydroxocobalamin sulfate......................7–5699 Homoeopathic preparations..7.................................................. 3248 Hyaluronidase ........................................................... 2438 Hydrochlorothiazide ..................... 8......3–4349 Human normal immunoglobulin for intramuscular administration.................. 2440 Hydrocortisone ............................EUROPEAN PHARMACOPOEIA 8..... 8........... 248 Human coagulation factor IX (rDNA) concentrated solution ......................5-hydrate ....... 8................................................................................................. 8.... 2448 Hydromorphone hydrochloride......)............. 254 Human antithrombin III concentrate ..... 8...........32.............. 2442 Hydrocortisone acetate ...13.................... 8.. Nux-vomica for ....................... 8..................................................31......................3–4348 Human hepatitis B immunoglobulin ................ 8......................7..................... 8.) ............) ....................................... 3220 Hydrous wool fat ........ pregelatinised ............. 266 Human prothrombin complex ....................3–4349 Human normal immunoglobulin for intravenous administration...........2–3991 Homoeopathic preparations.............7–5760 Human coagulation factor XI..3–4349 Human insulin .......................................... 262 Human haematopoietic stem cells............... iodinated (125I) ....3–4343 Human anti-D immunoglobulin............. 247 Human coagulation factor VIII ...................... 3303 Hydroxypropyl starch................... 1449 Hydrochloric acid................................................................ 2403 Honey bee for homoeopathic preparations.................21...................................... assay of (2.....................................................) ..... 8...... 8........ 8.......... 2462 Hyoscine hydrobromide ...............3–4357 Human tetanus immunoglobulin ........3–4359 Hydroxypropylcellulose............... 8.7 Homoeopathic preparations....30................................................................... herbal drugs for. colony-forming cell assay for (2.2–3988 Homoeopathic preparations....... 8............................7............8......................)..... 8.6–5284 Human C1-esterase inhibitor....................................................................3–4343 Human coagulation factor VII.................. 2455 Hydroxyethylmethylcellulose .............................3–4355 Human rubella immunoglobulin ..............................3–4351 General Notices (1) apply to all monographs and other texts Index Human papillomavirus vaccine (rDNA) ................................... 2404 Human anti-D immunoglobulin ................)..).............) ... 249 Human anti-D immunoglobulin for intravenous administration........................6–5299 Human measles immunoglobulin ...... cuprum aceticum for..3–4268 Homoeopathic preparations........ 3570 Hydroxocobalamin acetate ...............3................... low-substituted (5........... 2459 Hymecromone.................................. assay of (2.................... 2439 Hydrocodone hydrogen tartrate 2.... 2468 I Ibuprofen .....18............................... assay of (2......................................................................... 8................. 2419 Human hepatitis A immunoglobulin.............. nickel in (2......... 1450 Homoeopathic preparations...........................5............ 1441 Homoeopathic preparations................ 2337 Human haematopoietic progenitor cells............................ 150 Hydrogenated wool fat............................................3–4359 Human varicella immunoglobulin for intravenous administration..... petroleum rectificatum for ............................. 8...........2–3991 Homoeopathic stocks (methods of preparation of) and potentisation ...6–5291 Hypromellose phthalate .....................................6–5208 Homoeopathic preparations...................... assay of (2...................... 255 Human coagulation factor XI ....... 1429 Homoeopathic preparations............................ 8............ sulfur for ...... assay of (2... 2465 Hyoscyamus for homoeopathic preparations ......................... kalium bichromicum for ....... 3307 Hydroxyl value (2..... 266 Human albumin injection.. 2449 Hydrophobic colloidal silica.....................7–5759 Human C1-esterase inhibitor................................. 2418 Human glucagon..3–4266 Homoeopathic preparations... pillules for ..... hyoscyamus for ............... 1274 Human α-1-proteinase inhibitor ................................. 155 Hydroxypropylbetadex.............6–5208 Homoeopathic preparations........................................ 8....................................6–5286 Human coagulation factor VII........................ 8...... cuprum metallicum for ..........7–5763 Hydroxypropylmethylcellulose (5................. 8......... 261 Human protein C...... hydrastis canadensis for ............................................................. 8...2–3930 Human fibrinogen . hedera helix for ..........................) ....... assay of (2.................... Staphysagria for...........................7.. 1968 Hydrogenated soya-bean oil........................2–3987 Homoeopathic preparations... 8............. 8............................................. 8.. 2438 Hydrochloric acid......................... 1451 Homoeopathic preparations..7................................ 8........ 859 Human plasma for fractionation ............. 3305 Hydroxyzine hydrochloride.... 2454 Hydroxyethyl starches ........) .....................22................................................... 2407 Human antithrombin III............... 8......... Cocculus for ............. 8..............) .................... 2468 Hydroxypropyl starch................................... 8..................................................................................................... 265 Human protein S.................................................... 1584 Hydrogenated castor oil...... concentrated .............................8.......... assay of (2.....................7.................. 8................................... ferrum metallicum for................ assay of (2............... assay of (2............................................................................... 3569 Hydrogen peroxide solution (30 per cent) ......34..........7–5625 Hydroxypropylcellulose ....................................................7–5761 Hydrocortisone hydrogen succinate...7–5625 Hypromellose .. 8...........2–3989 Homoeopathic preparations............ 1450 Hypericum........... assay of (2..............................................)..... 1456 Homoeopathic preparations....................2–4050 Hydroxypropylcellulose (5......................................... Ignatia for ............) .....................................................2–3929 Human coagulation factor VIII (rDNA) .................................. human anti-D ............................ inactivated) ................6–5297 Insulin glargine ......................5–4927 Influenza vaccine (split virion................................ 8...4...................... 1065 Indium (111In) oxine solution ......... porcine ................... human measles ..........................10......................................3–4355 Immunoglobulin.....) .............. 2494 Insulin lispro ...... 123 Identification reactions of ions and functional groups (2.4–4691 Injections....................................................... 1067 Iobenguane (131I) injection for diagnostic use..................................................................5.................. feline ....................... 8.)........20...........................................................................2...... 8.............................................58............ test for Fc function of (2....................5–4989 Interferon beta-1a concentrated solution ................. human anti-D... approximate pH of solutions (2.............2.......... human normal............................................ 588 Immunosera for human use............................. 155 See the information section on general monographs (cover pages) .........)... 8....... 97 Inductively coupled plasma-mass spectrometry (2... 1069 Iobenguane sulfate for radiopharmaceutical preparations....................................................3–4357 Immunoglobulin.................9........ 1071 Inhalation powders..............)............ prepared in cell cultures) .............. 973 Infectious enteritis vaccine (live)....7.............6–5299 Insulin injection.. human..................................5..................) ...... assay of (5................................................) ................... human tetanus....13... inactivated)....................... 984 Infectious encephalomyelitis vaccine (live)... 8.............. 932 Infectious rhinotracheitis vaccine (live).............................................) ................ avian ..............2–3897 Intramammary preparations for veterinary use ... 2423 Immunoglobulin for intravenous administration............................................................................ preparations for .................. human hepatitis B...... 38 Infusions ........ 867 Influenza vaccine (whole virion..... 8....................... 689 Indapamide. human hepatitis B........................................... inactivated........ evaluation of efficacy of (5..................................................... 2502 Insulin zinc injectable suspension (crystalline) ................3–4357 Immunoglobulin......... soluble ........ inactivated................................................. 787 Intrauterine capsules . 159 Immunosera and vaccines.......................3........... 931 Infectious enteritis vaccine (inactivated)....... 870 Infrared absorption spectrophotometry (2............................................... 2478 Imipramine hydrochloride .......................................................................................)................................................ 8..1............ 8..........Index Iceland moss.........29....... 928 Infectious bursal disease vaccine (live)....................................................................3–4343 Immunoglobulin......................) ..................................... 2493 Insulin injection.......4–4692 Injections or infusions.................................................................. 8............................................................ 8... 604 Implants .. 803 Inhalation..6–5363 Iodine ............... 1003 Influenza vaccine (live... 8........... 787 Intrauterine tablets .)............ 8.............2–4055 Inductively coupled plasma-atomic emission spectrometry (2.... porcine..................... 1276 Indicators............... 309 Injectable insulin preparations....................................) .....7–5767 Imipenem monohydrate ......... biphasic isophane..........................................3.. avian ...................................6–5301 Insulin preparations......................... 8............ 8.............. 8........................... human rubella ..........3–4349 Immunoglobulin for intravenous administration............................................... 2475 Identification (2................................................8.... 587 Immunosera and vaccines.................9....... avian ......... anti-T lymphocyte.......5................... 748 Immunosera for veterinary use............................ 2501 Insulin zinc injectable suspension (amorphous) ................... feline ............) ............ phenol in (2. 8..........................24..................2................... evaluation of safety (5................... 929 Infectious chicken anaemia vaccine (live) ..........................................................................................) ............................................6–5303 Insulin zinc injectable suspension ..... 787 Intrinsic dissolution (2.................................. 1066 Indium (111In) pentetate injection ........... isophane ........ turkey ..............4–4692 Inositol.............. 122 Identification of phenothiazines by thin-layer chromatography (2......................... bovine ..... 8................... human normal. 119 Identification and control of residual solvents (2............................. 8...................... human varicella.................................................................. 119 Idoxuridine .. human hepatitis A ...................... 249 Immunoglobulin.........3–4348 Immunoglobulin.4–4692 Inhalation gas. 8.7............................ 8................................. 200 Immunoglobulin............................7 Infectious bursal disease vaccine (inactivated)............................ 2476 Ignatia for homoeopathic preparations .......................) ......) ................................... 1070 Iodinated (125I) human albumin injection .................................................2–4056 Interferons....... powders for...........7........................................... 787 Intrauterine sticks.............. preparations for : aerodynamic assessment of fine particles (2........57.) ... 8............... 787 Intrauterine solutions..............4–4693 Impurities in substances for pharmaceutical use............ krypton (81mKr).................7–5617 Ichthammol ............................................................................... veterinary.......................7....................3.........................................3–4348 Immunoglobulin....... 868 Influenza vaccine (whole virion. concentrates for ...... human rabies ............... 968 Influenza vaccine (inactivated)........24. 1275 ICH (5..............................................3–4351 Immunoglobulin........ 331 In vivo assay of poliomyelitis vaccine (inactivated) (2..............................................3–4349 Immunoglobulin for intravenous administration...................................................... 926 5868 EUROPEAN PHARMACOPOEIA 8.................18............................6–5091 Indigo plant leaf ........................ 748 Insulin aspart........ 2476 Ifosfamide ........... 8.......) ..................................................)....................................6.........................................6–5303 Injections ........................................................................................................................ assay of (2...................9................................. 8.2........ 8..........................) .......... 750 Immunosera for veterinary use............. avian....................) ..................)............ suspensions ................ 2505 Interferon gamma-1b concentrated solution .......17........4–4693 Injections or infusions...............3. human normal.. test for anticomplementary activity of (2....... inactivated................ 8....... 8.. virosome)........................ gels for........6. 865 Influenza vaccine (surface antigen.............................................................. human anti-D ...................................... 2511 Iodine value (2............................... 787 Intrauterine foams ..........7..................1.............................. 784 Instant herbal teas .... injectable................ animal ....................... 663 International System (SI) units (1................................. 1575 Immunoglobulin for intramuscular administration...............15............... 786 Intraruminal devices .....................................................) ... 591 Immunosera and vaccines....4.....2...... 2810 Inserts............................ equine ..................................................... nasal) ................ 8............................... control of (5.......... 925 Infectious bronchitis vaccine (live)........................9.....2... 8............................................. 2494 Insulin......... 2479 Immunochemical methods (2................................................................... 246 Immunological veterinary medicinal products........................................ 1064 Iodinated povidone .................. 2480 Indian frankincense......... prepared in cell cultures) .....................2... 2407 Immunoglobulin for intravenous administration.............. biphasic ...... 8....... 98 Infectious bovine rhinotracheitis vaccine (live)............................. 800 Inhalation........................... 2482 Indium (111In) chloride solution . 2434 Immunoglobulin for subcutaneous administration.................. evaluation of the safety of each batch (5.... 2493 Insulin injection.......................................)...............6............................... 2494 Insulin injection............................................................ 255 Iobenguane (123I) injection ........................ inactivated) .................................. 8....... myo..... ophthalmic.. substances of animal origin for the production of (5....3–4349 Immunoglobulin..2................3–4359 Immunoglobulin............................. 983 Infectious bronchitis vaccine (inactivated)..) ........................... 8.................... 974 Infectious laryngotracheitis vaccine (live)................ 1022 Influenza vaccine (inactivated)........................... 1066 Indometacin ..............3–4268 Imatinib mesilate ....... avian...................... 229 Immunoglobulin for human use........ 787 Intrauterine preparations for veterinary use ................. 8.... 2502 Interferon alfa-2 concentrated solution ....................... 861 Influenza vaccine (surface antigen.................................................................................................. human varicella................................................................................. animal ....3............. avian........) . veterinary..........................................) ..........................................3–4365 Insulin............................ 8..........................................................6–5191 Indinavir sulfate ............................2....................................4...................................... 141 Identification of fatty oils by thin-layer chromatography (2................................... 863 Influenza vaccine (surface antigen............................................................................. 1068 Iobenguane (131I) injection for therapeutic use... 8...... 2485 Insulin........................................ ........................................................ feline................. 8... 805 Isatis root ............... Thomson.................................................................................................. 2571 General Notices (1) apply to all monographs and other texts Index Ketotifen hydrogen fumarate ...7–5689 Ipecacuanha root .............2... 131 Iron for homoeopathic preparations................................................................... potentiometric determination of ionic concentration (2............. 2598 Leucine.......................... 8......................... 1286 Ketamine hydrochloride ... 8....................................................................... 85 Isoelectric focusing (2...... 8...................................................................7–5826 Lauromacrogol 400..............................................................................................................1–3787 Lansoprazole ............................................... 8.......................... heavy.................................................. 2532 Isoleucine................................36..................... 2597 Lemon oil.....................................9..................................3–4258 Java tea ................42.................... spike..................................................... 1289 Lavender oil................................................ prepared ........................ standard solutions for (4.........................6–5310 Isoniazid... 127 Limit tests...................................2........... 2567 Ketoprofen ................................................. 2621 Light liquid paraffin ........................................................................................................................................ 131 Leflunomide ........................................... canine . 8.......................1........ 1291 Lavender oil........................................................ 8............................. virgin ............................................ 2542 Isotretinoin ......................................................................) ... 2592 Largehead atractylodes rhizome .............................................1–3707 J Javanese turmeric.................................................................... 8............. 2612 Levomepromazine maleate.......) (5.............................................. 8................................................................... 1390 Lead in sugars (2.................. 8......................... 2543 Isoxsuprine hydrochloride.......... 1288 Kudzuvine root........................................................... 2527 Irbesartan.............................) ............................................................ 2518 Iopanoic acid .... 8..................................................................... 2601 Levamisole for veterinary use ............................ potentiometric determination of using ion-selective electrodes (2............. 2611 Levomepromazine hydrochloride........................3–4175 Liquid extraction preparations ............... 8.................. 2578 Lactic acid.................................1.............10............7–5690 Ipecacuanha tincture........ 2536 Isoprenaline sulfate....................6–5306 Ipecacuanha liquid extract.......5–4916 5869 .............................................................................7–5769 Ivy leaf ......4–4775 Levamisole hydrochloride ........9................................................................ 8................................................ 1128 Linoleoyl macrogolglycerides...6–5308 Isomalt (5............................................................1–3783 Knotgrass ..................... 2614 Levonorgestrel.............................................................. 2545 Ispaghula husk ..................................... 1295 Linseed oil........ 8........ diluted .......... 1295 Limit tests (2...... 2965 Light magnesium carbonate ... 8..................................................... 2594 Lauroyl macrogolglycerides............................. 1748 Lidocaine ............ 8......................................... sterile............2...............................8..................................... 1293 Leptospirosis vaccine (inactivated)...........................31................................ 2523 Ioxaglic acid.................................................................................................. 2494 Isoprenaline hydrochloride .... 2511 Iodohippurate (sodium) dihydrate for radiopharmaceutical preparations .................... 8.......................................................7–5626 Isomalt ......................) ........................ 2540 Isosorbide dinitrate..... standardised............................... 8...................... 2536 Isophane insulin injection ...............6–5094 Iopamidol................................................................................... 361 Liquid chromatography (2.................. 8....... calcium ...............................54.....................................) ....................................................... 1282 Isradipine ................. 2548 Ivermectin................................... 8....................... 2540 Isosorbide mononitrate....... 8............... 1160 Laryngotracheitis vaccine (live).......................................................... 2528 Iron (2......... infectious.....4................................................................................... 1280 Isoconazole ........................ 8............ 2604 Levocabastine hydrochloride ...........................................................2........................ 2596 Lavender flower .......................29..................... 2589 Lamotrigine ..... 1285 K Kalium bichromicum for homoeopathic preparations......................................................)................................................................................. 8..........................................7–5598 Lincomycin hydrochloride ...9...................3–4371 Lactulose.................................................................. 2563 Kanamycin monosulfate ....................................................................) ...... in distributor for veterinary use ......................................2......................... 2566 Ketoconazole ............ 2577 Lactic acid..................................4................................. 2624 Linseed ...........................................................2–4063 Levocarnitine.. dissolution test for (2..............................................6–5192 Josamycin.......... 8... sodium................ diluted ............................ sodium (5................................................. 1285 Juniper oil ................. 937 Leptospirosis vaccine (inactivated)............................................... 2622 Linen thread......8.....................................6–5306 Iopromide .......................................................... 2615 Levothyroxine sodium ................... 2520 Iotrolan ...................2........6–5316 Lactulose ................ 2557 Juniper... 932 Laser light diffraction.............................................................. 2607 Levodopa ........................................ 1745 Levomenthol............................................................. liquid............................................ 2539 Isopropyl palmitate.................... avian ...............................................................................................................EUROPEAN PHARMACOPOEIA 8...................................................................) .................................... 2531 Isoelectric focusing (2............1–3697 Leuprorelin .....................................6–5317 Leukaemia vaccine (inactivated)..8........ 8......................)............................................................................................................) .................. 119 Ion-selective electrodes..........................................................................................................................................) ............. 1071 Kudzuvine root ................... 2580 Lactobionic acid....................................................... 8............................ (S)...................................................................................................7–5688 Ipecacuanha................2–3990 Kanamycin acid sulfate .............................................................................................................................................. 2613 Levomethadone hydrochloride ....... 2587 Lamivudine...................................................... 2625 Lipophilic solid dosage forms.................................................................4–4776 Levetiracetam ......................... 1287 Krypton (81mKr) inhalation gas .... 2547 Itraconazole ............. 8.......54........ 2618 Levulinate dihydrate.........6–5094 Ions and functional groups.... anhydrous ... 2608 Levodropropizine.......) ...............................................................................36.................. 948 Letrozole ................. identification reactions of (2............ 1402 L Labetalol hydrochloride. particle size analysis by (2..........................................................................................2–4065 Liothyronine sodium............................................ 8...................................................... 2555 Josamycin propionate.................................................................................................................................................3......................... preparations for.....................6–5315 Lactose monohydrate ................................ 8.......................................... 2565 Ketobemidone hydrochloride ................................................) ....................................... 333 Laurilsulfate.................................................................... bovine.... 2581 Lactose.... 2610 Levofolinate pentahydrate............................................... 1070 Iohexol.......... calcium.................................................2–3989 Irrigation...................7 Iodixanol.........4............................. 8........................................ 1085 Iodomethylnorcholesterol (131I) injection................................... 2530 Isoconazole nitrate........................ 1281 Ispaghula seed ............ 1292 Lemon verbena leaf ..................................... standardised ..........................................................................................................................................................7–5691 Ipratropium bromide ..................... 2677 Lime flower.......................................................................... 2565 Kelp............................................ 8...................... 2564 Kaolin........................................) ...............................5–4991 Isopropyl myristate.....).......................... 2514 Ionic concentration............................................................... 2537 Isopropyl alcohol ........................................................................................................................................................................................................ 2579 Lactitol monohydrate ...................7–5629 Laurilsulfate......................................................... 2620 Lidocaine hydrochloride...........................................7–5617 Isoflurane ... 2671 Light magnesium oxide... 8......................................................................... 2569 Ketorolac trometamol .............. 8...................... 8......................................................... 8....... ............................ 2689 Mandarin epicarp and mesocarp.........................................................................................4........................... 2673 Magnesium citrate dodecahydrate......................................................................... oral ........2–3966 Loosestrife ...................................... 812 Lysine acetate ...................................................................................5.............................. 8......) ............ 2646 Lynestrenol .... 2685 Malic acid ............ 2641 Loss on drying (2.......................... 2638 Lorazepam .......................)...................................... 8.................................4–4518 Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components (3.. 1309 Marshmallow root ....................... 790 Liquids......5–4999 Macrogol lauryl ether...........................................9........................ 8.....................................................................................) ............... 1298 Lisinopril dihydrate ............................................. 1301 Lovastatin ..................) ................4–4815 Liquid sorbitol (non-crystallising) ..........................................................8.................. 8..................................................... 1521 Magnesium and alkaline-earth metals (2.................................. 375 Materials used for the manufacture of containers (3.......................1......... 2630 Long pepper ...............................1............ 2657 Macrogol 40 sorbitol heptaoleate.............................................................................................................................................)........................ 2656 Macrogol 30 dipolyhydroxystearate ............................................... 8.. 8.......................................2–4072 Maprotiline hydrochloride ......) ....................................... 375 Matricaria flower ......................)...... 8.............................................32..................................... heavy ..........7–5763 Lozenges and pastilles ........................... 8.. 2657 Macrogol 6 glycerol caprylocaprate.... 8................ 2673 Magnesium citrate nonahydrate ........................................................................................... 1305 Mallow leaf ..................) .... 2648 Lyophilisates............................... 8..) ............................................. 2694 Marbofloxacin for veterinary use .............. 331 Mass uniformity of single-dose preparations (2..... 276 Lovage root................................... 2679 Magnesium stearate (5............................4–4781 Marek’s disease vaccine (live)................. 1313 See the information section on general monographs (cover pages) ...........................................7 Magnesium carbonate............................ 795 Lubricant...............5–4888 Loss on drying of extracts (2............................14.................. 2660 Macrogol poly(vinyl alcohol) grafted copolymer ................................................. light...................3–4376 Magnesium sulfate heptahydrate ............................7–5626 Malathion..................................................... veterinary..... 8...7–5625 Low-substituted hydroxypropylcellulose ...........8..................................................... 8.................................................. refined ................9...............5–4995 Lymecycline.............................)................................... 2660 Macrogols ...........4–4516 Materials based on plasticised poly(vinyl chloride) for containers for aqueous solutions for intravenous infusion (3.) ......) .8.................................................................2–4071 Manganese glycerophosphate............................................................................. 8.......................................... 2674 Magnesium gluconate ....................... 8...........1..................................................................... 2668 Magnesium aluminium silicate. aqueous solutions (3............ 297 Mastic ............. 8........................11........ 2691 Manganese sulfate monohydrate ................................................ 2683 Magnolia officinalis bark ..................................................) ............................. 1300 Loperamide hydrochloride..........................4–4777 Lithium carbonate ......................... 2643 Low-molecular-mass heparins.................................................... 8..............................................1...............................................2–3991 Magnesium pidolate .......... 2677 Magnesium peroxide............................ 1310 Mass spectrometry (2......(2.......................................................................... clarity and degree of opalescence of (2. 98 Mass uniformity of delivered doses from multidose containers (2..........1............................................. 795 Lozenges...................................................) ...1...............................................)......)........1....................................4.).7–5692 Mandarin oil...............1.............................................................................................. 2683 Maize starch .................. partially dehydrated............................................4–4816 Liquid sorbitol............ 814 Liquid preparations for oral use ...1...... 8...................................................................... liquid ................................2–4070 Magnesium glycerophosphate.. 8... 1308 Manganese gluconate ....... 2655 Macrogol 20 glycerol monostearate............................4–4514 Materials based on non-plasticised poly(vinyl chloride) for containers for solid dosage forms for oral administration (3....1...............................................................8.............................................. 2633 Lopinavir...........7–5693 Matricaria liquid extract .......................... 2659 Macrogol oleyl ether.2............................................... 21 Liquid sorbitol (crystallising).............................................................................. 2691 Mannheimia vaccine (inactivated) for cattle....................................................... 1306 Maltitol................... 2675 Magnesium hydroxide.... 2634 Loratadine....2................................................. anhydrous.............. 8................ 1311 Materials based on non-plasticised poly(vinyl chloride) for containers for non-injectable..4–4511 Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components (3............................................... 789 Liquid preparations for cutaneous application....................................................... 8................3–4375 Macrogol stearate.................................................................... 3287 Liquorice dry extract for flavouring purposes ..... 987 Mannitol (5.......... 2665 Macrogols................................................. 1073 Lobeline hydrochloride................ inductively coupled plasma.....2............................. 8............7–5626 Mannitol ..........6.......2–4069 Magnesium (2.............7–5626 Magnesium stearate.................................... 2663 Macrogolglycerol hydroxystearate ........ high-molecular-mass .... 2670 5870 EUROPEAN PHARMACOPOEIA 8..................................................................................................................................................................................... 8................................................................58............................... 1304 Maize oil................4–4513 Materials for containers for human blood and blood components (3................................................. light .... 2341 Liquid glucose................................1.............................................................................................. 2966 Liquid preparations for cutaneous application .. 2649 Lysine hydrochloride.....................................1...................10........................................................ 2655 Macrogol cetostearyl ether .............................................. 2682 Magnesium trisilicate ................. 8..... 8............................ 986 Mannheimia vaccine (inactivated) for sheep ...............8..................................................................2...7.............................................................................................................................................) .................................... 2658 Macrogol oleate.......................... 2665 Macrogol isotridecyl ether................... 2342 Liquid lactulose............1... 8...................... 2685 Maleic acid...................... 2631 Loperamide oxide monohydrate. 8...... 128 Magnesium acetate tetrahydrate .................................... 2684 Maize starch (5......................................................................... 2671 Magnesium chloride 4...............................................5–4916 Liquid glucose ............................................................ 2676 Magnesium oxide................... 2671 Magnesium chloride hexahydrate .27............ 8..... 8..........43................ 1296 Liquorice root ...................................... 2587 Liquid maltitol ................... 128 Magnesium aspartate dihydrate................................ 8........ 2392 Low-substituted hydroxypropylcellulose (5.................................... 393 Lufenuron (anhydrous) for veterinary use ........................................ 8................................... 2672 Magnesium citrate.................................................................................... 2687 Maltitol............... heavy.............................. 2677 Magnesium oxide....).................................Index Liquid (fluid) extracts ............................................. 2688 Liquid paraffin ..............................................................5-hydrate................ 2688 Maltodextrin.... 2678 Magnesium phosphoricum for homoeopathic preparations .............................. silicone oil (3.....) ..........3–4375 Magnesium lactate dihydrate .................................1–3709 Magnolia officinalis flower ..............) ............................................................................................................................................. 2669 Magnesium carbonate.............. 69 Mass spectrometry........ 2658 Macrogolglycerol cocoates...... 2686 Mallow flower..... 8..6–5319 M Macrogol 15 hydroxystearate .17........... spray-dried ....................8.......... 8................................................................................................ 2628 L-Methionine ([11C]methyl) injection ........................................ 2664 Macrogolglycerol ricinoleate ................. 989 Marshmallow leaf . hydrated ......2–4069 Macrogol stearyl ether ....................................... compressed .................. 2639 Losartan potassium ............................................................................................................................. 2662 Magaldrate................................................... 2629 Lomustine ................................................................................................................2.......... 2628 Lithium citrate ........... ..5–5001 Miconazole ............... 803 Metered-dose preparations for inhalation.......... methanesulfonyl chloride in (2............................. methyl............................7–5618 Microbiological assay of antibiotics (2................9...........................7–5669 Menthol........................................................................................................... 2766 Metronidazole ........................................... 2744 Methyl.........................................6–5329 Methylene chloride.........5.................... determination of (2.. 2720 Mesterolone .......... 2698 Medicated chewing gums .................................................................. 8................................................................ 8....... 32 Melting point ........................ 8....................................)........EUROPEAN PHARMACOPOEIA 8...... 2711 Mepivacaine hydrochloride . 8.................................... 2699 Mefenamic acid............................................... nonpressurised.............2....................................................................7–5778 Methylthioninium chloride ................... ethyl and isopropyl methanesulfonate in methanesulfonic acid (2.................. mumps and rubella vaccine (live)............................................9.......................................7 Matricaria oil........................................................................................................) .. 230 Microbiological control of cellular products (2............................ 2738 Methyl parahydroxybenzoate.................................................. 1316 Measles immunoglobulin........ 2741 Methylene blue..... 8.................................................................................. 2727 Methacrylic acid ...........................9..... 304 Methenamine ........ 2696 Meclozine dihydrochloride................................37......12......7. 8............... pressurised .......................................................... 2745 Methyl methacrylate .....open capillary method (2...6–5328 Methylpyrrolidone........................................................................................5.......5..... 8.....9................................ racemic .... 812 Medicated vaginal tampons............ 2760 Metoclopramide hydrochloride ....6–5323 Methionine..............................................) ................. 1492 Medicinal air....) .......ethyl acrylate copolymer (1:1).... 8................... ethyl and isopropyl benzenesulfonate in active substances (2.............12....................................... 185 Microbial enumeration tests (microbiological examination of non-sterile products) (2... 8.......15....... 555 Methotrexate ......................................................5..............5......................... dissolution test for (2................................................................. 2754 Methylrosanilinium chloride ..........2....7–5469 Methanesulfonic acid.............14........... 169 Methyl.. 8........4.........................6..... 2755 Methyl salicylate ..................................... 8...................... 8.... 809 Medicated tampons ......................................................8................................6.......................... 2712 Meprobamate ........9..... 2715 Mercury porosimetry..... 1494 Medium-chain triglycerides ............................. 110 Measurement of consistency by penetrometry (2............................................................................... ethyl and isopropyl methanesulfonate in (2................ 8............................ 784 Medicated plasters ............... 2722 Metabisulfite.... 8.....................................) . premixes for .... 2721 Mestranol .......................3–4379 General Notices (1) apply to all monographs and other texts Index Methanesulfonate (methyl..............12............11...................... 800 Medicated foams......... 171 Methanesulfonic acid..................... 216 Microbiological examination of herbal medicinal products for oral use and extracts used in their preparation (2.....) ................................ 2731 Methane ...............6............................................31............................................................................... 185 5871 ......................................3–4378 Melilot ......................................) ........................... 3254 Metacresol.................................... 2761 Metolazone .........................................................................................................) (5...38..................... 2769 Mexiletine hydrochloride ....)....................... 8..................................................... 2717 Mesna .................. 1073 Methionine ............................................. 8..........7–5627 Methylcellulose ...... basic butylated .............3–4384 Mianserin hydrochloride . 133 Metamizole sodium monohydrate....................) .........................................21..... 8...3–4349 Measles..............).......... 781 Medicated chewing gums........................................................................................... 3073 Metabisulfite....... 801 Metformin hydrochloride....................... 2768 Metronidazole benzoate............ 8......................) ................................... 325 Medicated feeding stuffs for veterinary use..............................) . 3471 Medronic acid for radiopharmaceutical preparations ...3–4381 Methylcellulose (5............... 2710 Meningococcal group C and haemophilus type b conjugate vaccine ...... 8............................................ 814 Medicinal air .instantaneous method (2.......................................................................) ....1.................7–5470 Methyl.................2....................... 1314 Meadowsweet .................................... ethyl and isopropyl) in active substances (2......................................6–5324 Methyldopa....................................................5–4999 Melphalan . 8.....40................................. 2728 Methacrylic acid .........) ................) ........................).......... potassium ................... 2746 Methylphenobarbital ..................................... 105 Melting point ................. 2734 Methods in pharmacognosy (2.................39...........6.................................... 3255 Methylpentoses in polysaccharide vaccines (2......... DL..... 2723 Metal catalyst or metal reagent residues (5........................... 872 Measles................................................................37......1–3791 Metered-dose preparations for inhalation............ 8.....................6.....4–4501 Methylhydroxyethylcellulose...............................).........................................3–4383 Methylergometrine maleate .............methyl methacrylate copolymer (1:1)............................7–5469 Methyl.......................................................60................................5–5002 Miconazole nitrate......)................................ 8....38.......................................................... 8..............4–4785 Metrifonate ...... porosity and pore-size distribution of solids by (2.................. 2747 Methylprednisolone.......................................................... 2706 Meldonium dihydrate. 2730 Methadone hydrochloride ................6–5326 Methylprednisolone hydrogen succinate ......methacrylic acid copolymer (1:2)............ 8.methyl methacrylate copolymer (1:2).................8................... 2733 Methionine ([11C]methyl) injection.................. synthetic.. test for (2........................... 2713 Mepyramine maleate...................25.............................................. 336 Meropenem trihydrate .......................methacrylic acid copolymer (1:1)............ 1072 Medroxyprogesterone acetate...................) ..................... 2704 Meglumine..... 8.............7–5667 Meningococcal polysaccharide vaccine . N...4–4784 Metoprolol tartrate ...) ................................................................ 8....5–4888 Melting point – instrumental method (2...2.................... 171 Methanol..............32....5.................. 1319 Meloxicam ...................... 2739 Methyltestosterone ..... 2759 Metoclopramide.......... sodium...............................................................) ...........................41)..................................... ethyl and isopropyl methanesulfonate in active substances (2...............5...............7–5775 Mesalazine ..................................... 2737 Methyl parahydroxybenzoate..................... 2729 Methacrylic acid ..................20.....................)............ 2762 Metoprolol succinate ......27........................................................................... 32 Menadione........................4–4782 Methacrylate copolymer.....)....... 271 Methods of preparation of homoeopathic stocks and potentisation ..................) ..................................7–5665 Meningococcal group C conjugate vaccine .................... 8........................................................ 2701 Mefloquine hydrochloride.......................................................................7–5776 Methylprednisolone acetate................................................. 2708 Melting point .............................................capillary method (2. 2729 Methyl methacrylate .....................8............ 8........16............................... rubella and varicella vaccine (live) ..........................)..6–5329 Metixene hydrochloride................... 874 Measurement and detection of radioactivity (2............... human .. 8............................... 1624 Methacrylic acid ...............................................................................................66................................... 873 Measles vaccine (live)...............................) ...2.....................ethyl acrylate copolymer (1:1) dispersion 30 per cent ................5..................................................................... 2715 Mercuric chloride ............ L.............................. ethyl and isopropyl toluenesulfonate in active substances (2........................................ 8..... mumps............. 2730 Methyl nicotinate.............................6–5197 Methods of preparation of sterile products (5..................)..... 222 Microbiological examination of non-sterile products : microbial enumeration tests (2........... 8.........5.... 733 Metal catalyst or metal reagent residues......2................................ 161 Methylphenidate hydrochloride ...................... 2732 Methanol and 2-propanol...............39........................................... 299 Mebendazole ............................. 169 Methanesulfonyl chloride in methanesulfonic acid (2..............1.......................... sodium......... 8............................ 8................................................................................................... 8..............................).............. 1318 Melissa leaf dry extract ...................................6–5331 Microbial enumeration tests (microbiological examination of non-sterile products) (2.......................................................................20................................ 2702 Megestrol acetate .... 1317 Melissa leaf ............................. 2714 Mercaptopurine ......................... )......... 2829 Narrow-leaved coneflower root .............................................................. 873 Mumps vaccine (live) ................................................)...... characterisation of preparations for (2........................................................................................................ 753 Monocyte-activation test (2............................ 2797 Morphine sulfate........ 8.......................................................8.......... 1321 Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (5........................................................................................ 8............................ 8.... 8.............................................6........7–5780 Milk thistle dry extract..... 331 Mumps.......) (5. 8.................................................... 150 Nickel in polyols (2...... 8............ 1324 Mouthwashes....... 796 Mullein flower .....8.................................) .............7–5695 Neurovirulence test for poliomyelitis vaccine (oral) (2....................... 990 Mycoplasmas (2...... 2837 Nettle leaf............ 8.................................. 2840 Newcastle disease vaccine (inactivated)...............................6–5337 Nalidixic acid ........................................................ 2808 Mycoplasma gallisepticum vaccine (inactivated) ................................................................7–5779 Micro determination of water (2.....) ............ liquid preparations for ...................... 879 Mupirocin ........................... 8....................................................................32............................23) ............61............... 1332 Nicergoline .....................7–5618 Microbiological examination of non-sterile products : test for specified micro-organisms (2.......7–5787 Naloxone hydrochloride dihydrate...... 3-O-desacyl-4............................................... 189 Microbiological examination of non-sterile products : test for specified micro-organisms (2............6–5339 Nicotine.................. 995 Newcastle disease vaccine (live)..37.. 571 Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use (5..... 2781 Misoprostol.......................... 2800 Moxifloxacin hydrochloride ................................................................. general texts on (5......................................... 792 Nasal preparations.6.... 8............................................ 1320 Milk thistle fruit...)................... 1479 N-Acetyltyrosine .1............................................ 2804 Mucoadhesive preparations.....15.............. 997 Niaouli oil.................................... 2803 Moxonidine ..........................2............................. 2783 Mitomycin ................ 8........... 2834 Neonatal piglet colibacillosis vaccine (inactivated)....7........... 793 Nasal preparations ........................................... 560 Microbiological quality of herbal medicinal products for oral use and extracts used in their preparation (5.................... 2826 Naproxen ......6... 2825 Naphazoline nitrate ...23.... 2831 Near-infrared spectroscopy (2...................... 792 Nasal sticks ... 1824 Microcrystalline cellulose and carmellose sodium ....................................................................1........) .....3–4390 Neroli oil ..................................... 8...................................... refined and standardised ...............................................................................................................................................................8. 786 Modified-release tablets .................................... 794 Moxidectin for veterinary use............................................................9..... Iceland...................6–5105 Microscopic examination of herbal drugs (2........ 994 Neostigmine bromide................................) ...................................................... 2846 Nicotine resinate ....................2......................................... 2849 Nifedipine ............................................................. 8.......................................).............. optical (2.................4.............. 2844 Nicorandil........................................................... 2791 Molybdate dihydrate.......................................... 555 Microcalorimetry and solution calorimetry...........13............ 62 Nebulisation......... 2815 Naftidrofuryl hydrogen oxalate .......................6.................) .......................................19...............................................................................................................) (5........ 2808 Molecular mass distribution in dextrans (2...... 2813 N-Acetyltryptophan ............................................................................................... 2786 Modafinil ......................................................................18..37.........................................................................1.............. sodium ............... semi-solid.................................) ............................................................................................................12............) ....2...39........ anhydrous ............................................................) ........................................................................... 8..................................................................................................................................... 559 Microbiological quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use (5.).. 2807 5872 EUROPEAN PHARMACOPOEIA 8.................................................................... 2779 Minoxidil ...........8.............................................. partly dementholised ............................................. 2799 Moss..................................... 282 Microscopy.......................................... 2845 Nicotine ditartrate dihydrate..............2............................................................ 780 Modified-release granules........................................ 2839 Nevirapine hemihydrate ...................... 178 myo-Inositol .........................................................................) (5...............) (5................................................................... 2780 Mint oil.......................5–4911 Monophosphoryl lipid A.............................................................. 8............1............................................................ 132 Niclosamide.......................................................................................................5.................................6.............. 801 Neohesperidin-dihydrochalcone ...6....40................7–5661 Nandrolone decanoate ................... 2796 Morphine hydrochloride ..... 811 Mofetil mycophenolate ..... 2854 See the information section on general monographs (cover pages) ..................................................................................................................... rubella and varicella vaccine (live) ...................................................... 349 Microscopy..........7–5620 Midazolam.......... 60 Molgramostim concentrated solution................27........................ 363 Nebulisation...........4................................................ 1481 Nadolol.............................................................................................................................. 2822 Names of herbal drugs used in traditional Chinese medicine (5............................) ........................... 8................... cineole type ..............).......... 2833 Neomycin sulfate .... 1327 Nasal drops and liquid nasal sprays ...................................... 1329 Netilmicin sulfate..................................................................7 Mycobacteria (2...... 992 Neonatal ruminant colibacillosis vaccine (inactivated)...... 793 Nasal sprays (liquid) and nasal drops ..............................) .................4–4791 Naproxen sodium ...... 2792 Monoclonal antibodies for human use .............................................. alternative methods for control of (5...................................................................................................................................... 792 Nasal powders ................... 1275 Mother tinctures for homoeopathic preparations ......... 2851 Nifuroxazide.................................................. 2824 Naphazoline hydrochloride ...........................).................................................... 2843 Niclosamide monohydrate ..................................................................... 2000 Montelukast sodium......) ......................... 8.. 2814 Nadroparin calcium ................................................................... anhydrous ............... 2853 Nikethamide.............................................. 991 N Nabumetone ................. 3256 Mometasone furoate.......................................................4.................................................6–5338 Nicotinamide..........6.. 217 Monographs on herbal drug extracts (information chapter) (5............... 202 Nevirapine....................................)........................................ 8....................................6............. 178 Mycophenolate mofetil . optical (2..........................................................3–4391 Nicotinic acid ........................ 2805 Mupirocin calcium ...............................................................................31........................................... 2850 Niflumic acid.............................. 202 Neurovirulence test of live viral vaccines (2......................................................7–5782 Mitoxantrone hydrochloride .1–3715 Motherwort .................. measles and rubella vaccine (live).............................9........... 872 Mumps....... 1326 Myrrh tincture .. 793 Nasal washes....44.......) ..................................................................) ..................................................................... 106 Microcrystalline cellulose ...................... 2820 Naltrexone hydrochloride... 8....... characterisation of crystalline solids by (2...)... 592 Minocycline hydrochloride dihydrate.............................)........................8...............................6.........7–5621 Microbiology......................30.............4....................... 8.................................... 2788 Molsidomine ................3–4389 Neostigmine metilsulfate .............. 1325 Multidose containers.)................................) ..............8..........9.... 2787 Modified-release capsules ................................... 1327 Myxomatosis vaccine (live) for rabbits .............................................................................................9..................1.......13.....22.......... 2794 Morantel hydrogen tartrate for veterinary use .................... 1323 Mirtazapine ...2.......) ....................8.... measles........... 1331 Nettle root....................................................7–5618 Microbiological quality....Index Microbiological examination of non-sterile products : microbial enumeration tests (2.......................................... uniformity of mass of delivered doses (2...... 8.. 793 Nateglinide ................................................................................... 2810 Myrrh ............ 2841 Nickel in hydrogenated vegetable oils (2........... .....9................................................ 2858 Nitrendipine ....... 2913 Ondansetron hydrochloride dihydrate ...........................................64.....................................................)...... 790 Oral use..............................................................12.............6–5341 Nitric oxide..) (5...............5......................... 2899 Olive oil............8.................................................... microbiological quality of (5................................................... 2871 Norethisterone ............................ fatty.............. 811 Oromucosal capsules............................................64.................. emulsions and suspensions............ 1334 Nux-vomica for homoeopathic preparations ..... 8...............4...........................................2–3921 Nucleic acids in polysaccharide vaccines (2...................................................6–5345 Orphenadrine hydrochloride ................... total cholesterol in oils rich in (2....5.................................... 189 Non-sterile products................. 8....................................................9........................................ peptide identification by (2.. microbiological examination of (test for specified micro-organisms) (2....................................................... 8..3... 2918 Oregano .......) (5..................)......................... 160 Oseltamivir phosphate ..............................................................................................33.............................. microbiological examination of (test for specified micro-organisms) (2..7–5618 Non-sterile products.......................................................................................................... 2869 Noradrenaline tartrate ........................ human ..................................................................12..................4................. 793 Oromucosal suspensions and oromucosal solutions.....17........ 109 Nucleated cell count and viability (2.......... 794 Oromucosal preparations .................................................13....................4......EUROPEAN PHARMACOPOEIA 8...................................... 8...... fish oil rich in ........................................2.....................29................................ 2893 Odour (2....................................................................7 Index Oak bark ......................... 52 Nuclear magnetic resonance spectrometry.. 2236 Omega-3 acids..............................................) ............................................. 2895 Oils............................... 3273 Oriental cashew for homoeopathic preparations ....) ........................4............................. 2874 Norfloxacin............................................................................. essential....... 2877 Norgestimate ............... clarity and degree of (2................ 8.......................................... oromucosal drops and sublingual sprays. 775 Oils rich in omega-3 acids.........................3–4351 Nortriptyline hydrochloride... oromucosal sprays and sublingual sprays...... 790 Oral use............................................................4............................) .. 2901 Olsalazine sodium ............... 1344 Orodispersible films ....................................... 8.....33...... 8........................5......................................29.................. 1335 Octoxinol 10.....35.... 1342 Organ preservation.2....................................... 349 Optical microscopy (2.............6–5101 Omega-3 acids............................................... raw.................. 2865 Nitrous oxide in gases (2.1.................................................) .................. 2856 Nimodipine ........................................................................................................ 793 Oromucosal preparations................................ 163 Nitroprusside............................................26.............................................. 168 Nizatidine ...... 2884 Normal immunoglobulin for intramuscular administration........................) ........ standardised .... 8....................................................... 8..................) .............32..........................) ....... 21 Ophthalmic inserts .............) ....................1–3689 Orbifloxacin for veterinary use.............................................. standardised. 2868 Nonoxinol 9................................................2................ 8....................2..... 123 Odour and taste of essential oils (2... vegetable........2.. microbiological examination of (microbial enumeration tests) (2............................... human ..............................................................7–5620 Optical rotation (2..........6................. 795 Oromucosal drops.......................................8...... 263 Nucleic acid amplification techniques (2.......................... 2905 Omega-3-acid ethyl esters 90 ... 2900 Olmesartan medoxomil ..............................2......................................... semi-solid .............. 258 Nutmeg oil .................................. liquid preparations for .... 8............ 8........1.......................N-Dimethylaniline (2......................)................) ............................ 2872 Norethisterone acetate ......................................................... virgin .8...................... 8............................................................................. 8........... 8....7–5788 Nitrazepam ............................. 559 Non-sterile pharmaceutical preparations and substances for pharmaceutical use......................) (5.............26...........................).....................................................).................. 2893 Octyldodecanol ..5........................ 812 Oral powders......) ..................... 2915 Opalescence of liquids............................. 122 Oils...................6..................................7–5621 Non-sterile products............ 784 Opium dry extract...........6–5382 Nitrous oxide....... 160 Numeration of CD34/CD45+ cells in haematopoietic products (2........................................................... 26 Oral drops............. peptide identification by (2..... sodium ...................................................8..................................... 2898 Oleoresins ..................... 2883 Norgestrel ...................................2...37..... 2859 Nitric acid ................................................ 2896 Oleic acid ........................ 2862 Nitrofurantoin................... 794 Oromucosal sprays.......................... total cholesterol in (2......................... 2898 Oleyl alcohol.................................... 2863 Nitrogen determination by sulfuric acid digestion (2.............................5–4951 Opium.................35. 2911 Omeprazole magnesium ......................................................................................................3......................... primary aromatic amino (2.........)...........6............................................13................................................................................) (5........... 8......... 2871 Norepinephrine hydrochloride . 8.................................................. 8.. 799 Oral solutions...................................... 2909 Omeprazole .............).......................................8.......................................................). 8........................... 1337 Olive oil................. 2863 Nitrogen ...... 2423 Normal immunoglobulin for subcutaneous administration............................................................................................................................. identification by thin-layer chromatography (2......5–4953 Opium tincture.............. 2912 Omeprazole sodium ........... 185 Non-sterile products........ 157 Nitrogen determination............ 796 Orodispersible tablets ......)........7.. 2861 Nitrofural . 2899 Olive leaf ...............................) ..... 8...................... 2864 Nitrogen monoxide and nitrogen dioxide in gases (2...................................) .4.......5–5007 Notoginseng root ..................................) ........................................................................ 791 Oral lyophilisates ...........................................) ..21......... fatty... 2894 Octyl gallate............................................7.............. 808 Olanzapine............................................................................................... 157 Nitrogen...........3–4270 Nystatin.5–4917 Oleoyl macrogolglycerides .......8.............................. 2903 Omega-3-acid ethyl esters 60 ................. 2886 Noscapine hydrochloride hydrate.....................................7–5618 Noradrenaline hydrochloride.............................3–4349 Normal immunoglobulin for intravenous administration........4........... 2869 Norepinephrine tartrate..19.......................... prepared ........... 794 Oromucosal solutions and oromucosal suspensions..5.9..... human .........................................)......................... 8......................)............... 52 NMR spectrometry................................................................ 2869 Non-sterile pharmaceutical preparations and substances for pharmaceutical use................................................................. microbiological examination of (microbial enumeration tests) (2.................... 2922 Osmolality (2............ 2866 N-Methylpyrrolidone ........................................................4.......................................................... 8.............. 743 Oils.............................) ..............................).. 2888 General Notices (1) apply to all monographs and other texts 5873 .) .............1..................................2................ 1333 Nuclear magnetic resonance spectrometry (2............................................ low-oxygen......... veterinary semi-solid preparations for ...................................................................... 2916 Orciprenaline sulfate ....5........... microbiological quality of (5........................... 2884 Noscapine . 2875 Norflurane .....7. composition of fatty acids in (2................................................................................................................ 793 Orphenadrine citrate..... composition of fatty acids in oils rich in (2.......................... 8....................................................................... 2754 NMR spectrometry (2................................6–5101 Oils rich in omega-3 acids........................8.........) ........... 151 Omega-3-acid triglycerides ................................) .......................................2–3981 Orientvine stem ...............37......................... 2907 Omega-3 acids........................................................ refined .....................................................29........ 1335 Olive leaf dry extract .....32...................................................23........................................6...............6–5346 O O-Acetyl in polysaccharide vaccines (2...................5–4952 Opium..........................)..... solutions for.. 151 Ointments ...6........... 146 Nomegestrol acetate ................. 109 N....... 57 Nilutamide....................... 2855 Nimesulide...........................)........................................... 272 Ofloxacin..................................5–4955 Optical microscopy (2........................ ... 2929 Oxcarbazepine................ 859 Paraben........... 2953 Pale coneflower root.........................8............ 1004 Parvovirosis vaccine (live).....................................................................8................18.............................................. 8....... 1712 Parahydroxybenzoate...........)................................................... 3006 Penicillin V potassium ................... sodium ethyl ......... 8................................. anhydrous .......................... 351 Particle-size distribution estimation by analytical sieving (2....................................................... 8.....................38................................................) (5....................................... wild (flowering aerial parts)......................30... butyl ................................... 2975 Penbutolol sulfate ........ feline ...................................... 2738 Paraben......... 323 Parvovirosis vaccine (inactivated)......................................6–5347 Oxazepam ..... 42 Papillomavirus vaccine (rDNA).............. 2984 Pentetate sodium calcium for radiopharmaceutical preparations ........ 2191 Parahydroxybenzoate............................................................................. 164 Oxitropium bromide ...55......... butyl ............................................. calcium .....................9................... 309 Particle size analysis by laser light diffraction (2.......... 997 Paramyxovirus 3 vaccine (inactivated) for turkeys......55.................... sodium propyl............................................................. 1749 Papaverine hydrochloride.. diphtheria and tetanus vaccine (adsorbed....................34.. 1349 Pepper... 2945 Oxytetracycline hydrochloride. 2983 Pentazocine lactate ................................................................................................................ 8..................................................1–3795 Oxytocin ...................... 974 Pansy........................................ 3007 Pentaerythrityl tetranitrate.................................................................. 2956 Pamidronate disodium pentahydrate........ 798 Patches......... 308 5874 EUROPEAN PHARMACOPOEIA 8................................ transdermal ...............5. 1650 Penicillin G sodium........ 3243 Paraben...) ... 2960 Pantothenate. 2942 Oxygen-flask method (2.................................. 1352 Peppermint oil .................... 1651 Penicillin V ......................................... white soft......................... light liquid ..... 8.............................................................................8......................... 1648 Penicillin G.................... ethyl ................9............ procaine............................................. 2940 Oxygen ......................................................................... hard................................................................................. 8............. 2948 Oxytocin concentrated solution.................................... 2965 Paraffin..........................................27. 8........................).............................) (5.............................. 295 Pea starch.. 2982 Pentazocine hydrochloride .......................5–5011 Peroxide value (2.....................................................................................................................9.. 1353 Pepsin powder.............................................5.................................. 8.......... 826 Pertussis (acellular.................6–5350 Oxfendazole for veterinary use ....................................................................)..............2.................................................................. 2994 Permethrin (25:75) ..........................5................................... 2962 Paper chromatography (2. test for extractable volume of (2...................................... acetic acid in (2............................ 2931 Oxeladin hydrogen citrate .... 2977 Penetrometry..................... 8..... 3255 Paraben.................................................................................................. 333 Particle-size distribution estimation by analytical sieving (2..) ..7–5795 Perindopril tert-butylamine ............. 938 Parainfluenza virus vaccine (live)............................. human ......................... 1347 Pastes ................................ liquid ............... canine .......................................) ...................................8.....................6–5105 Perphenazine..................... 2984 Pentobarbital sodium .................... 2956 Pancreas powder ........................ 995 Paramyxovirus 1 (Newcastle disease) vaccine (live)....................................................... 973 Panleucopenia vaccine (live)......................... 2967 Parahydroxybenzoate.. methyl ..................................................... 321 Particulate contamination : sub-visible particles (2......64.................. sodium ethyl.7–5620 Particulate contamination : visible particles (2............... 8......................................... 8................................................................ 2966 Paraffin.............. yellow soft .................... hydrated sodium ......)................................. 2959 Panleucopenia vaccine (inactivated).............................. propyl....................... bovine ... 1074 Oxygen (93 per cent)....... 2988 Pepper .........................................................................).......................2............6–5175 Pentobarbital ........................................................................................................... 8................) (5. 2996 Pertussis (acellular.................................. canine......9......... 2925 Oxaliplatin .......................... 2924 Oxacillin sodium monohydrate ............................ aerodynamic assessment of in preparations for inhalation (2........... 2963 Paraffin.......................5....................................... 3255 Parahydroxybenzoate... component)........................................................................................ sodium propyl....................................................2–3966 Peppermint leaf..... 2971 Particles............ test for extractable volume of (2............ porcine.................................................................. 3243 Parahydroxybenzoate......................... 168 Perborate..............................................31............7–5793 Pelargonium root ................................................. 2939 Oxycodone hydrochloride ...) .............) ..........................................19...... solutions for ............19..........................)............. 3263 Parainfluenza virus vaccine (live)......................)..... 109 Peptide mapping (2.. 8...9........ propyl ........................... synthetic..........7–5620 Parnaparin sodium .................................................7–5618 Peptides............... 2191 Paraben.9................ 951 Passion flower ......... 950 Parvovirosis vaccine (inactivated)................................................... long...) ........... fine........................ 8.9........................................................... 1712 Paraben.............4–4691 Parenteral preparations.....................1–3693 Parenteral preparations....... 299 Penicillamine..) ....................................................................................9..........38......................2–3951 See the information section on general monographs (cover pages) ................................................................... dissolution test for (2.. 999 Pastilles and lozenges .... 8.............................. 163 Oxymetazoline hydrochloride.. avian............. 2991 Peritoneal dialysis.............9........................4......................... reduced antigen(s) content)..................................................... 2985 Pentoxifylline ...................... 2968 Paroxetine hydrochloride......... feline .7 Parenteral preparations..................................................................................................................................... 1347 Passion flower dry extract ................ 1350 Peppermint leaf dry extract............. 8............................................................................................... 8....................... transdermal..................................................) .............26.................20.................................... 2978 Penicillin G.. 807 Patches............................. 2934 Oxolinic acid ........................................................) .. 2933 Oxidising substances (2......... avian ................................................................7–5794 Pentazocine...................................................................... 1647 Penicillin G potassium ................................................................................................................................... 2937 Oxybuprocaine hydrochloride ......................................... 809 Pasteurella vaccine (inactivated) for sheep...............................................................................2. 2949 P Paclitaxel .................................................................................................... 1345 Palmitic acid.................................................................................................. 2980 Pentamidine diisetionate .7–5620 Particulate contamination : sub-visible particles (2... diphtheria and tetanus vaccine (adsorbed) ............................... component).......................................................1–3799 Pefloxacin mesilate dihydrate..... 1348 Pemetrexed disodium heptahydrate............................................ 2941 Oxygen (15O) ...........................5...............6–5355 Pancuronium bromide .. 158 Oxygen in gases (2................................................ 8................5........... 2738 Parahydroxybenzoate..................9.... canine... 2989 Peptide identification by nuclear magnetic resonance spectrometry (2................................................................................................................................) ................................... 2943 Oxytetracycline dihydrate.... 949 Paraldehyde ........ 795 Patches.... 3258 Pergolide mesilate....Index Ouabain ................... measurement of consistency by (2...................................................... 3263 Paracetamol .............................. 2968 Paramyxovirus 1 (Newcastle disease) vaccine (inactivated).............................................. 2986 Pentoxyverine hydrogen citrate ....................................................................... cutaneous....... diluted..............................................................................................6–5351 Oxprenolol hydrochloride ............ 3122 Paraben.................... methyl .....9.... 1420 Pantoprazole sodium sesquihydrate.................. 2966 Paraffin.................................................. avian .................17....................................2.............. 2938 Oxybutynin hydrochloride ... sodium methyl..................................... 2969 Paroxetine hydrochloride hemihydrate .) (5..).................................... 8..................... 87 Peptide mapping (2................... 2964 Paraffin..... sodium methyl ... 3122 Parahydroxybenzoate....17...........................................)....9........................ ethyl..........................................10.............................................................. 8......... benzathine..) ........ .............................. human........ 1441 Pilocarpine hydrochloride ......................................................................13.................... 3017 Phenytoin sodium.......... 8.................. hepatitis B (rDNA)........................................ adsorbed)............. component).... 3003 Phenolsulfonphthalein ....)................... tetanus..5........ 842 Pertussis (whole cell). diphtheria.2...................... poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) ........................................................................2..... component)....8...........1.. 3043 Piperazine hydrate .. sodium ........ assay of (2.............. component) and haemophilus type b conjugate vaccine (adsorbed) ............................ tetanus..................................... 889 5875 .......................................... 3013 Phenylephrine hydrochloride.............................. 3014 Phenylmercuric acetate.. tetanus and poliomyelitis (inactivated) vaccine (adsorbed............................. diphtheria...........8........................... diphtheria.....2...................... tetanus and hepatitis B (rDNA) vaccine (adsorbed) ...............6–5113 Pethidine hydrochloride ......9........5.....3–4264 Pillules........................... 419 Pneumococcal polysaccharide conjugate vaccine (adsorbed) ...) ............................................. 2425 Plasma (pooled and treated for virus inactivation).................................................. 3046 Piretanide.............................. 24 Phthalylsulfathiazole ...................................................... concentrated.... 8.............. diphtheria........................................ 3019 Phloroglucinol............................................ component) vaccine (adsorbed)............11.............................2.... 398 Plastic containers and closures for pharmaceutical use (3........................... poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) ................................................................... 8. 3050 Pivmecillinam hydrochloride.......................................................... approximate (2................... tetanus..................................................... component) vaccine (adsorbed............. 3007 Phentolamine mesilate ..... tetanus and pertussis (acellular................8................................ reduced antigen(s) content) .............. 3029 Picosulfate............. 3003 Phenol in immunosera and vaccines (2............................................ 835 Poliomyelitis (inactivated)...........7–5799 Pimobendan .......................3–4396 Piperacillin sodium ................................................ 271 Pharmacopoeial harmonisation (5........ 131 Phosphoric acid.... 3044 Piracetam ......... human ......... bacterial cells used for the manufacture of.. tetanus and poliomyelitis (inactivated) vaccine (adsorbed).... 8...... 3025 Phosphoric acid.. 3000 Phenobarbital ...................................................... 837 Poliomyelitis (inactivated)........) .............................. 3011 Phenylbutyrate................................................................................................. 827 Pertussis (whole cell)......................................6–5357 Pheniramine maleate....................7–5797 Phenylalanine ............... diphtheria...................... 835 Pertussis (acellular................... porcine enzootic ..........)......................).... 8.................. 3036 Pine (dwarf) oil.................................. 2997 Petroleum rectificatum for homoeopathic preparations.................................................................... diphtheria.....................) ....................... sterile (3............................... diphtheria............ tetanus and pertussis (whole cell) vaccine (adsorbed) ...................................................................2...... 840 Poliomyelitis (inactivated)......3–4353 Plasmid vectors for human use...8......................................... coated ............7–5670 Pneumococcal polysaccharide vaccine ............................................. 3027 Phytomenadione ........ 8............................................................................................ 707 Plasmin inhibitor............................ 992 Pillules for homoeopathic preparations....... adsorbed)...........) .... 8. methods in (2....................... 807 Plastic additives (3................................................. tetanus and pertussis (acellular..........................25......... 287 Pesticide residues (2......................................... pertussis (acellular......) ......... component............................... diphtheria and tetanus vaccine (adsorbed) .................. 830 Pertussis (acellular.......................................... 834 Pertussis (acellular......2............................................................. 3030 Picric acid for homoeopathic preparations ................................................................................. tetanus and poliomyelitis (inactivated) vaccine (adsorbed) ................................................................................2..... 3051 Plasma for fractionation........... 3037 Pipemidic acid trihydrate ......................... sterile (3...................................)... tetanus......... 1354 Pessaries ................................ 261 Plasters.. anhydrous ...........)..........2.................15. hepatitis B (rDNA) and haemophilus type b conjugate vaccine (adsorbed).................................. 880 Pertussis vaccine (acellular............ 160 General Notices (1) apply to all monographs and other texts Index pH.......2........................................). neonatal .................................. 3005 Phenoxymethylpenicillin ............................................ 8..... 285 Pharmacognosy.................................................... diphtheria......................................) .......... 3002 Phenol ...... medicated .................................................................................. 3017 Phenytoin............................. 3022 pH of solutions. 8................................................... 21 Physostigmine salicylate .. poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) .... 3006 Phenoxymethylpenicillin potassium ......... 844 Peru balsam ..........................................................................6–5208 Pharmaceutical preparations.EUROPEAN PHARMACOPOEIA 8....7–5617 Phenazone....................................................... pertussis (acellular............... 834 Poliomyelitis (inactivated)....7 Pertussis (acellular..................................................................................... assay of human (2............................. 224 Pertussis vaccine (acellular).........................................7...................... 242 Pertussis (whole cell).................. 842 Poliomyelitis (inactivated).... homoeopathic.. 3038 Piperacillin......... 8........................................ diphtheria........) ................... 1001 Poliomyelitis (inactivated).... 3025 Phosphorus in polysaccharide vaccines (2.............................................3..............................3–4395 Phytosterol.................................... homoeopathic.................... 8.....)....... 3016 Phenylpropanolamine hydrochloride ......................................................... co-purified.............................................................................................. 1441 Pillules. 3041 Piperazine adipate ...... 3045 Pirenzepine dihydrochloride monohydrate ....... 832 Pertussis (acellular........... identification by thin-layer chromatography (2........ component).................7–5699 Piglet colibacillosis vaccine (inactivated)........... 3033 Pimozide .......... component)......................... 3047 Pirfenidone .. 8......................................................... 3001 Phenobarbital sodium.............................................. dilute .......... 8.................. 8............................................... 3020 Phloroglucinol dihydrate ...... 8...........16................. 1230 Pine sylvestris oil ..............................................................) ................. impregnated...................... component)................... 3034 Pindolol.................) .............................6–5359 Piroxicam......... 159 Phenolphthalein.... tetanus............... 123 Phenoxyethanol ...)............7......................................... reduced antigen(s) content)....... 756 Pharmaceutical technical procedures (2...................... 837 Pertussis (acellular.................................... 882 Pertussis vaccine (whole cell.............................................................3................................. component).............................................................. single-use................................. pertussis (whole cell) and haemophilus type b conjugate vaccine (adsorbed) ....7–5798 Pilocarpine nitrate ........... component).........................................1............ 3024 Phosphates (2....... adsorbed) ... 844 Poliomyelitis vaccine (inactivated) ........ 3260 Picotamide monohydrate...7....................................7.. 8.................) ................. 3004 Phenothiazines................................................... diphtheria......... 252 Pertussis vaccine (acellular.......... 3016 Phenylmercuric nitrate ....... 8.... 3258 Phenylephrine ......... 8.....................................................................4...) ........... diphtheria....... 840 Pertussis toxin (residual) and pertussis toxoid (irreversibility of) (2... 813 Pessaries and suppositories............. diphtheria and tetanus vaccine (adsorbed. diphtheria.... tetanus......2........................................ 414 Plastic containers for human blood and blood components....................... 3042 Piperazine citrate .......... diphtheria..... disintegration of (2...13.......7–5673 Pneumonia vaccine (inactivated).....18.......................................2–4085 Phenylbutazone............................................................................................................................................. 883 Pertussis vaccine (whole cell)..........3............................. 3048 Pivampicillin ...4...............6..............) ..............................................)..................................... 415 Plastic syringes......................... 3015 Phenylmercuric borate...............9................................... assay of (2..... 3026 Physical and physicochemical methods (2... 1355 Pioglitazone hydrochloride ................................ reduced antigen(s) content).......................6–5091 Pholcodine.33.... potentiometric determination of (2..................................................................... tetanus and haemophilus type b conjugate vaccine (adsorbed) ..........................................................4–4530 Plastic containers for aqueous solutions for infusion (3. 829 Poliomyelitis (inactivated)........................................... diphtheria....... sodium ....3........................... .........................................................................................11.......... oral ....... plasticised.. 383 Polymorphism (5.............................. 160 Polysaccharide vaccines................................................) ................... 8....................................9.... 336 Porosity and pore-size distribution of solids by mercury porosimetry (2...........) (5................4–4511 Poly(vinyl chloride)..................4–4518 Poly(vinyl chloride)..........1.... sterile....... inhalation ................... 8.. 1363 5876 EUROPEAN PHARMACOPOEIA 8................................................... 3070 Potassium disulfite.............. 2665 Polyoxyl hydrogenated castor oil ..................................................................................45........................ 891 Poliomyelitis vaccine (oral)...........................................9.......................5–5013 Polysorbate 40 ............ 160 Polysaccharide vaccines....45....5–5015 Polysorbate 80 (5............19.1......................4....36............... 8.) ............. 793 Powders........................................4–4802 Potassium carbonate... 3065 Potassium citrate............................................................) ... wettability of porous solids including (2...) ......... 160 Polysaccharide vaccines.....3.........1........1..... 202 Poloxamers ............) .........................2........... 3065 Potassium clavulanate ...............4–4516 Poly(vinyl chloride).....................)......32................................................... 164 Polysaccharide vaccines.......................................................................5......................... effervescent ................................36........ 3061 Poly(vinyl alcohol)..... 8.................. 8...........................6–5091 Potentisation and methods of preparation of homoeopathic stocks...1.............................................................) ...................................................................35..........7–5627 Polysorbate 80 .... 8..............1..2... 15 Porous solids including powders....... 403 Poly(ethylene terephthalate) suture......6–5361 Polystyrene sulfonate.......... in distributor for veterinary use ..... 8....................) ............... 8..1....................................7–5800 Poly(vinyl alcohol) macrogol grafted copolymer ...20.................... 3073 Potassium metabisulfite .5....................................4–4513 Poly(vinyl chloride).....) ...................................) ...5........................................................................................................ in distributor for veterinary use ................... 391 Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations (3....................................... non-plasticised..............5....... 336 Porosity of sintered-glass filters (2.... 161 Polysaccharide vaccines.......................... 161 Polysaccharide vaccines.............................................. 1129 Poly(ethylene ....2......................................... 2664 Polyoxypropylene stearyl ether .. protein in (2................................2...... 784 Powders for injections or infusions.................. 3064 Potassium chloride .... nasal.....) ..) ..........) .........21................... high-molecular-mass............................................... high-molecular-mass .........7 Porcine actinobacillosis vaccine (inactivated) .. materials based on for containers for aqueous solutions for intravenous infusion (3............................. 3072 Potassium hydroxide ....9............................ 8...............2..........9.........9..23...........5..................... methylpentoses in (2......................... in distributor for veterinary use ....................................5...................2........ 1004 Porcine progressive atrophic rhinitis vaccine (inactivated) .... 3066 Potassium clavulanate. 791 Powders and tablets for rectal solutions and suspensions..................................).................. 3055 Polyolefins (3. 803 Powders...............................)............................................10.......................................... wettability of (2.............. 8.......................................... nucleic acids in (2........................)............................................14...............................................32.. 1005 Pore-size distribution of solids by mercury porosimetry....17..................................................5–5016 Poly(vinyl acetate) dispersion 30 per cent ..... 782 Powders............ 388 Polysaccharide vaccines for human use.. 132 Potassium acetate...3–4375 Polyethylene oxides..... 800 Powders for cutaneous application.. materials based on (3.......... 3078 Potato starch (5...................6–5360 Polypropylene for containers and closures for parenteral preparations and ophthalmic preparations (3........... plasticised............... plasticised.................6.1..5.................. 346 Powder flow (2..... 3077 Potato starch.8................................ 8.........................................5–5014 Polysorbate 60 ............ 418 Poppy petals................ 8.......................................... 791 Powders and granules for syrups .... sterile containers of for human blood containing anticoagulant solution (3.... 8...........22......... 8........)............... 24 Potentiometric titration (2.................................................9...........8........................ 336 Poria .......) .....................5........... 3078 Povidone................. 8........ 3073 Potassium nitrate ..................4–4692 Powders for oral drops.................................32...... 2665 Polyethyleneglycols................................... materials based on for tubing used in sets for the transfusion of blood and blood components (3............. 2660 Poly(vinyl chloride) (non-plasticised) for containers for solid dosage forms for oral administration...............................................................................3............... 8.. 380 Polyoxyl castor oil........................... 8.........................).. 8........ mercury. 384 Polyethylene without additives for containers for parenteral preparations and for ophthalmic preparations (3...............9............ 3083 See the information section on general monographs (cover pages) ........) ...... phosphorus in (2............ 3076 Potassium sorbate ..................... ribose in (2............. 3063 Potassium bromide............... carrier proteins for the production of (5........ 807 Powders......)........ 8...................................).... conjugated. 8......5...... 3071 Potassium hydrogen tartrate ................. 791 Powders......................... 3261 Poly(vinyl acetate) .......... 1828 Powder fineness (2..) ......................................................................2........................................... 160 Polysaccharide vaccines.............................................. 1128 Polyamide 6 suture............................) .......) ..................36................... 1001 Porcine influenza vaccine (inactivated) ..6–5197 Poultices... 3074 Potassium perchlorate................................................. 8...............8. 3070 Potassium hydrogen carbonate .....7............. 161 Polysorbate 20 .................................11.................. in vivo assay of (2.........4................................... red........................................3–4375 Polyethylene terephthalate for containers for preparations not for parenteral use (3... 8................7.................................. O-acetyl in (2....34.......)..... 255 Poliomyelitis vaccine (oral) ............. 3075 Potassium sodium tartrate tetrahydrate ...9...........................4–4514 Poly(vinyl chloride)......1............ diluted................ 1003 Porcine insulin ............ 799 Powders for eye drops and powders for eye lotions .......... 3076 Potassium sulfate .... 8................. sterile.15.......................................................................................................... 3068 Potassium dichromate for homoeopathic preparations....) ...................... 1000 Porcine enzootic pneumonia vaccine (inactivated) .....7–5627 Potentiometric determination of ionic concentration using ion-selective electrodes (2..... bulk density and tapped density of (2.......... 159 Polysaccharide vaccines...1..............)....................................................... ear ..... 8....... 1356 Porosimetry.............. 809 Pour-on preparations ..........) ..... 8........... 3082 Pravastatin sodium ............31....... test for neurovirulence (2..................................................... 3054 Polyamide 6/6 suture.................. plasticised....... plasticised................. 365 Potassium (2....)..........Index Poliomyelitis vaccine (inactivated)..........................18................ empty sterile containers of for human blood and blood components (3...............................................................9....................5–5012 Polyacrylate dispersion 30 per cent.......4.................................................................................19........................................................... sialic acid in (2. 799 Powders.................................9...1...............16....... iodinated.......) .............5......... sterile................. uronic acids in (2..6–5363 Potassium iodide..................)........... materials based on for containers for non-injectable aqueous solutions (3..... 346 Powder flow (2.2–3990 Potassium dihydrogen phosphate................................................................1..................3–4205 Polysaccharide vaccines.................... 365 Pramipexole dihydrochloride monohydrate ........5..) .........................................) .......)........................... 814 Povidone .) ..........6....... sodium ...........................................................)...6–5301 Porcine parvovirosis vaccine (inactivated)..... hexosamines in (2.....5–4901 Powders...................... 8...................................................6–5363 Powdered cellulose ..................................................................)...1............... porosity and (2.....................................................6–5094 Potentiometric determination of pH (2.............................. 8...... 1128 Polyethyleneglycols............................................vinyl acetate) for containers and tubing for total parenteral nutrition preparations (3..................).................) ................................20................................... 417 Poly(vinyl chloride)....... 3075 Potassium permanganate..................)......) .............. 3073 Potassium hydrogen aspartate hemihydrate . 685 Polymyxin B sulfate ........ 8.............7–5620 Powders and granules for oral solutions and suspensions ................. porosity and pore-size distribution of solids by (2...2...12..................................1........... materials based on for containers for human blood and blood components (3.. 8................20............................1.......................... ....7–5807 Rabeprazole sodium hydrate....... 3103 Prochlorperazine maleate ..................................................................................6–5367 Quinine hydrochloride ......).1.................. 3130 Pyrazinamide ..............................................................................................30................3–4355 Rabies vaccine for human use prepared in cell cultures.....................6............1–3807 Quinidine sulfate .......... 8..... 8.....................9... 800 Preparations for inhalation ..................7–5633 Raloxifene hydrochloride .................. 8................................................... medronic acid for .....................................6–5175 Radiopharmaceutical preparations.............. 3133 Pyrimethamine .7–5475 Premixes for medicated feeding stuffs for veterinary use .............................................) .... 8.......................... 3090 Prednisolone acetate............................6–5364 Propylene glycol dilaurate ..................... copper tetramibi tetrafluoroborate for......... 2711 Racemic camphor ............7................................ flocculation value (Lf) of diphtheria and tetanus toxins and toxoids (2................................. 3124 Propyphenazone ...........................................................) .....................31........................... pentetate sodium calcium for ...7.......................... 8....) ...................................................................... 1362 Quinapril hydrochloride....... 3091 Prednisolone pivalate .............................................8..... 309 Preparations for irrigation........................................................... 3104 Products of fermentation......... 3108 Promethazine hydrochloride.....................................48.................................8............................................................... 763 Products with risk of transmitting agents of animal spongiform encephalopathies .....................3–4398 Prilocaine hydrochloride . table of physical characteristics (5...........................7–5608 Primidone .....................................7–5801 Pregelatinised hydroxypropyl starch ........................................................................... sodium iodohippurate dihydrate for..1.................... microbiological (5...66.............. 8..........................................) ................................................1–3801 Propanol and methanol........................................................ 1110 Radiopharmaceuticals.................. 8.... 159 Protein S......................... 1356 Probenecid.................................................... 8.............................................................................................)................................................................28...1–3799 Prednisolone.......... 8........................................7–5483 5877 ..) ................ 304 Propantheline bromide ........................... 805 Preparations for nebulisation : characterisation (2........ 8.................. 1357 Pullulan.............. 3106 Proline................................. 3109 Propacetamol hydrochloride............................. 3305 Pregelatinised starch......................................... 8...........3–4399 Primaquine diphosphate..... 8............................................... 3127 Proxyphylline ................... 2143 Raclopride ([11C]methoxy) injection............ 3121 Propyl gallate.....................4................................. 8......... 1011 Racecadotril......................................................7 Prazepam ....................... 8................................. 3122 Propyl parahydroxybenzoate................) .................2–4091 Quillaia bark............................................................................................................................................................... 8............................................................................................ 1070 Radiopharmaceutical preparations.................................................................................................. 8...................................... 8... 8.....................................................................................7–5621 Quantified hawthorn leaf and flower liquid extract............................. microbiological (5............. 8.................. 759 Progenitor cells............ 262 Progesterone................................) (5...... 3306 Prekallikrein activator (2................... 8... 3101 Primula root .................................9....................................................................................................................6–5173 Radiopharmaceutical preparations........ 3114 Propofol ...........7–5808 Rabies immunoglobulin...... 3128 Pseudoephedrine hydrochloride...................3–4400 Procainamide hydrochloride................................................................ 800 Preparations for inhalation : aerodynamic assessment of fine particles (2................. 3115 Propranolol hydrochloride .............. iobenguane sulfate for ................ 3121 Propyl parahydroxybenzoate............................................) ......... 1072 Radiopharmaceutical preparations..8... 157 Primary standards for volumetric solutions (4.........9.........................23...7–5483 Reagents (4..... 8.................... 3102 Procaine benzylpenicillin .............................................) ...................................................... 3107 Promazine hydrochloride .... 3093 Prednisolone sodium phosphate.)..................................... 3119 Propylene glycol monolaurate......................... 8...................... 2-.................. 266 Protein................. 165 Prothrombin complex.................................................................. human......................11....) ....... human haematopoietic........... 3134 Pyrogens (2................7............... 8.......................) ................................. total (2...................... 265 Protein in polysaccharide vaccines (2.............. 2143 Racemic menthol ...................) .............................................................................................. 8.......................................................................... 3110 Propafenone hydrochloride.................1......... human .................... colony-forming cell assay for (2.............................................................) ... 3150 Raman spectroscopy (2................................................) ........................... 3125 Protein C.... 3559 Purple coneflower herb......... 363 Pressurised pharmaceutical preparations....................6–5368 Quinine sulfate....... sodium .................................. 8............2................................. 3086 Prazosin hydrochloride... 1359 Pycnometric density of solids.......7–5464 Ramipril ....................................... extemporaneous preparation of (5........................................................ 2711 Racephedrine hydrochloride......................................................................4–4805 Racementhol............................. 3112 Propanol......... 8............................. 8.................................... 3561 Purified water............................................................. highly......1–3802 Protamine sulfate...............6–5139 Radiopharmaceutical preparations ........................ 1008 Rabies vaccine (live...................................................... determination of (2............. 3129 General Notices (1) apply to all monographs and other texts Index Psyllium seed..... 2429 Protirelin......................7–5812 Rapeseed oil............................7........... 3087 Prednicarbate ...................... tetra-O-acetyl-mannose triflate for .....................................................................................................27.................... 3120 Propylene glycol monopalmitostearate...................................... assay of (2........ oral) for foxes and raccoon dogs ................................................... 3155 Reagents (4.. 110 Radionuclides.. porcine .............15................... 8........................ refined ...............................................) ....................................... 559 Quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use....... 1007 Rabeprazole sodium .............. 3118 Propylene glycol dicaprylocaprate........................................)................................ 1085 Radiopharmaceutical preparations.....................................................) ... detection and measurement of (2.......5......................................................................................... 1357 Purple coneflower root .............................................2............................................................................................ 8............ 3099 Primary aromatic amino-nitrogen......1.....2–3952 Rabies vaccine (inactivated) for veterinary use ........................5–5017 Praziquantel..................16..2........................ 759 Radiopharmaceutical preparations................................................................................... test for (2.......... 3094 Prednisone........................7......................1.......... 183 Pyrrolidone... 8....................... 261 Ranitidine hydrochloride........................................6–5370 R Rabbit haemorrhagic disease vaccine (inactivated) .................... 3117 Propylene glycol. human..................... 758 Products of recombinant DNA technology.. gas (2............................................................... 8..................................................................................................5–5018 Progressive atrophic rhinitis vaccine (inactivated)............................................. 1005 Proguanil hydrochloride...........................7–5810 Ramon assay.................................. 3135 Q Quality of non-sterile pharmaceutical preparations and substances for pharmaceutical use......................................................5................................. 1076 Radioactivity.......... 3095 Pregabalin ............................ 1274 Quetiapine fumarate ..) ..........................).......... 8....................................... 3121 Propylene glycol monostearate ............ 3131 Pyridostigmine bromide ..33... 8...............................................................................................................................................................EUROPEAN PHARMACOPOEIA 8. 3263 Propylthiouracil .............44......................................18...................3–4248 Pyrantel embonate..................................... 8........3–4404 Purified water ................................ 1753 Racemic ephedrine hydrochloride ...............................5...... 805 Prilocaine.... 1650 Procaine hydrochloride...............................................19.......................) ....................................................................... 3132 Pyridoxine hydrochloride............6............... human............. 324 Pygeum africanum bark .........9..................... assay of (2...................4....................................................... ................................................ feline .............7–5814 Ropivacaine hydrochloride monohydrate ........... measles and mumps vaccine (live) ..................... 8............................................................................... 807 Rectal tampons... standard solutions........................................ 1377 Saw palmetto fruit .............................. 8.................................................... 2462 Scopolamine hydrobromide ............................................2–3968 Safflower oil............5–4956 Senna pods............... 1013 Salmonella Typhimurium vaccine (inactivated) for chickens .................. 3437 RRR-α-Tocopheryl acetate...................... buffer solutions (4.................... 807 Rectal preparations......... 940 Restharrow root ..............7–5628 Rice starch ..........................................2................................................................................................................................................................................................................ 8.................2–3987 Sage leaf (Salvia officinalis) .................4.......................................... refined.................................................................. 8.................. 8................ neonatal............................ 8........................................................................................................................................................9................ turkey . 806 Rectal solutions.8................. 3209 Sertraline hydrochloride.............................................................) ......... 8..................... 3157 Residual pertussis toxin and irreversibility of pertussis toxoid (2......................................................................................................7–5819 Safety....................... 1381 Scopolamine ............. Tinnevelly ... 3439 RRR-α-Tocopheryl hydrogen succinate ..................... measles............ 8..................................................................... 8.........................................3–4357 Rubella................. 1219 Semi-micro determination of water (2....... 1370 Rosuvastatin calcium................................................................. 8..........................) . 8... oral).......................................................... 3181 Roman chamomile flower...........................) ..........................................................................) .......... 157 Saquinavir mesilate... 28 Rotation........... 902 Sialic acid in polysaccharide vaccines (2............. 161 See the information section on general monographs (cover pages) ....................) ............................. mumps and varicella vaccine (live)................................................................... oral) for chickens ........................ 8......... refined.................................. 8........... 224 Residual solvents (5......................................1–3813 Salmonella Enteritidis vaccine (inactivated) for chickens........9..............................33...............3–4407 Saccharin sodium (5... 1022 Rhinotracheitis vaccine (live).........................................................................4................2–4101 Selenium disulfide ................................. feline ......... standardised ........................................................... 3193 Saffron for homoeopathic preparations. 3210 Sesame oil............................................................. 1367 Rice starch (5......... 1015 Salmonella Typhimurium vaccine (live........... 8........... 3158 Respiratory syncytial virus vaccine (live).. 3201 Salvia miltiorrhiza root and rhizome................................................ 976 Rhinotracheitis vaccine (live)....... 1363 Reference standards (5....................3–4249 Rhinotracheitis vaccine (inactivated)...........5..............).............................................2............)................5-hydrate................................... 72 Serine....... 8........................................) ................. 8........................ 8........................................ 727 Rectal capsules ...... 3185 RRR-α-Tocopherol........................................................................................................... 8.... 3207 Selfheal fruit-spike....................7–5822 Shampoos ............ viral.................3–4248 Rhatany tincture ...... bovine......... 1016 Salmon oil.............. 8...................................) .............................. 983 Rhinotracheitis vaccine (live).......10..................................12...................... 2464 Selamectin for veterinary use..8............................................... 3216 Shingles (herpes zoster) vaccine (live) ............................................2.. 1376 Saponification value (2.. Alexandrian....................5–5023 Rilmenidine dihydrogen phosphate ..... 3160 Riboflavin sodium phosphate .........6–5375 Risperidone ....................................... 1366 Ribavirin ........................................................... 3208 Sertaconazole nitrate ............................ 8............................. 794 Semi-solid preparations for cutaneous application ............................. 977 Rhubarb .......... viral.....................................24.....4–4681 Refractive index (2..... 8.................................. 8..............1.........3–4250 Sage leaf....................................................... 944 Rotavirus vaccine (live. 26 Rotavirus diarrhoea vaccine (inactivated)..........................................8.................................................. 8............viscosity (2.......................) ...................5.............................. 787 Semi-solid nasal preparations . 3183 Roselle .....................................1–3689 Semi-solid rectal preparations ... farmed ..... 3159 Riboflavin.. 3195 Salicylic acid ................. 299 Resorcinol ......... 2461 Scopolamine butylbromide ...........................8............. 164 Ribwort plantain ... 8.......... 793 Semi-solid oromucosal preparations.....................................7 Rubella immunoglobulin..............................2–3967 Retroviridae-derived vectors for human use...... powders and tablets for.... 806 Rectal foams ............ 807 Red poppy petals.................. 1374 Sanguisorba root................ chromatographic (2................ 900 Ruminant colibacillosis vaccine (inactivated).................................. calf ..... 3179 Rocuronium bromide. 813 Senega root .......................... products of........... 3443 Rubber closures for containers for aqueous parenteral preparations.........................................5.. 872 Rubella........................................................................ 8.. 3169 Risedronate sodium 2..................12..... 639 Residual solvents............................................ 3193 Salbutamol sulfate........ 994 Rutoside trihydrate ...... 421 5878 EUROPEAN PHARMACOPOEIA 8............. 8.) ..................................................................... 898 Round amomum fruit ..........................2..................................................................... 8.................... 1374 Salbutamol .......9............................1..................................................................) ............................5............4–4807 Rotating viscometer method .. 1389 Sage tincture ................................................... 3187 S Saccharin (5..........................2–3970 Sage oil.)........................7–5628 Saccharin sodium ................................. 8............... for powders and for freeze-dried powders (3.................) .........................................5–5027 Selegiline hydrochloride . 3164 Rifampicin ...........................................2.....).............. 807 Rectal solutions and suspensions...........................6.................7–5628 Saccharin...................... semi-solid............................................................................................. 3156 Reserpine ...............3–4252 Senna pods........................ 8................................................. veterinary ...................................... 3176 Rivastigmine hydrogen tartrate ....................... Spanish................... common ....46....................................) ................ optical (2.................................................................... 3165 Rifamycin sodium......................... 26 Relative density (2.......3–4251 Senna leaf dry extract................................7.............................) ........ three-lobed ..............................................................) ........................................... emulsions and suspensions.................. 418 Sevoflurane .......................................) . 272 Resistance to crushing of tablets (2.............................................................................................. infectious.......... 3198 Salmeterol xinafoate .... 3212 Sets for the transfusion of blood and blood components (3.....................8.. infectious....) .31... 1368 Rosemary leaf....................................7–5820 Saw palmetto extract ....................................................Index Reagents... 3162 Ribose in polysaccharide vaccines (2.......................................4–4806 Rifabutin ...................................... 25 Repaglinide.........................................................1........ 1379 Schisandra fruit.............. viral (5............... 807 Semi-solid preparations for oral use......................6–5376 Rizatriptan benzoate .....................................6............................................ 3171 Ritonavir ............................ 727 Recommendations on methods for dosage forms testing (5.............. 8............................... 1012 Salmonella Enteritidis vaccine (live........ bovine ...23..........................................) ..................................................................... 782 Semi-solid eye preparations .......................... 3173 Rivastigmine.................5–4891 Semi-solid ear preparations....................... 763 Recommendations on dissolution testing (5.......................................6.......................................................................17......7....................................) ......................................... 8........................................... 790 Shellac .................................................5... identification and control (2.............3–4253 Separation techniques..............................................2–4097 Rifaximin ......17...................................... 1382 Senna leaf...................................................................... 784 Semi-solid intrauterine preparations . 712 Rhatany root......................... human ........................2............................................... 873 Rubella vaccine (live) ..................................................................7–5483 Recombinant DNA technology......................) .................2..... 807 Semi-solid vaginal preparations ...................... 1369 Rosemary oil ..................................1–3710 Roxithromycin .... 8............... 8.............................................................................................................. 1206 Ropinirole hydrochloride ..... 141 Residue on evaporation of essential oils (2...............................................6............... 806 Rectal preparations.............................. 8............ 571 Safflower flower .............. oral) for chickens ............)..................................... ...................................8..................6–5384 Solubility in alcohol of essential oils (2.... 3268 Sodium sulfate............. 8......................... 1969 Sodium carboxymethylcellulose...............................9..........) .................................)...............1–3814 Sodium chloride (5..6.............................. 8...22.....9................................................. 1521 Silicate..............................8.......9. dental type................................ analytical..... 727 Solids by mercury porosimetry.......8...... 336 Solids.................................... braided...... 2579 Smallpox vaccine (live) ............ 3250 Sodium hydroxide .....9..............4–4813 Sodium chromate (51Cr) sterile solution................................................................) ..........................................................7–5628 Sodium chloride...... sterile.................................... 3257 Sodium nitroprusside.................... 8..................................... 3232 Sodium bromide .........5–4917 Solid dosage forms.............................. intrauterine..................................................8. 393 Silk suture.............. 787 5879 ............9..............1................................................6–5381 Sodium aminosalicylate dihydrate ......................................... 1524 Silicone elastomer for closures and tubing (3...................... 1085 Sodium lactate solution ................. 8........ 8............................................ 3242 Sodium disulfite ........................ anhydrous ......... 8.4–4763 Solutions for haemodialysis....................1.....8..........................7 Siam benzoin......................... 8........ 8. anhydrous ........ 3260 Sodium polystyrene sulfonate ..................... 8......................................................................................2................. 8..............) . 365 Solifenacin succinate ......... 297 Sintered-glass filters (2............................. hydrated ...............6–5382 Sodium iodide........................................... 1092 Sodium picosulfate .............. 8...45..........................7–5619 Solid dosage forms..32.................... 324 Solids (porous) including powders..................... 3217 Silica......) ...........................................7–5629 Sodium starch glycolate (type B)..... 16 Sieve test (2.............. 1091 Sodium phenylbutyrate....... 8..... 3219 Silica..............................61.......... 3255 Sodium molybdate (99Mo) solution (fission) ........................ colloidal hydrated............7–5824 Size-exclusion chromatography (2..................................................................................................4–4813 Sodium calcium edetate............. 3221 Silver nitrate ................... uniformity of mass (2.......... 8..........................)............ 1079 Sodium fusidate ................................................................... 1084 Sodium iodide (131I) solution for radiolabelling .................)............. 106 Solutions. 2375 Solutions for haemofiltration and haemodiafiltration ...7–5827 Sodium metabisulfite .........................8........3–4410 Sodium ascorbate ..................................................................... 3270 Sodium sulfite... 3264 Sodium selenite........................ 3245 Sodium glycerophosphate...................................................4. 3251 Sodium iodide (123I) injection ........................2..3–4412 Sodium stearate................................................ hydrated....... for external use......... particle-size distribution estimation by (2.......................................... 3261 Sodium propionate ......2....... particle-size distribution estimation by (2........................................ 8........................... 3243 Sodium fluoride ........................................3–4280 Sodium carboxymethylcellulose..)........................................................ 3234 Sodium carbonate.......... 3273 Solutions for peritoneal dialysis................................3–4408 Sodium alginate ................................... 8........ 1078 Sodium acetate trihydrate..................9.............. 3229 Sodium aurothiomalate ..... 1171 Sieves (2.......EUROPEAN PHARMACOPOEIA 8........................ wettability of (2................ 3241 Sodium dihydrogen phosphate dihydrate ............................... 3223 Single-dose preparations............................ 3253 Sodium starch glycolate (type A) (5.) .....................6–5383 Sodium (S)-lactate solution.. 3252 Sodium laurilsulfate (5.. uniformity of content (2..................................................9..... 3220 Silicate............6–5117 Solid dosage forms..................................................................................... 3233 Sodium calcium pentetate for radiopharmaceutical preparations .........9..) ..... hydrophobic colloidal ..................... anhydrous ...... 8................................................) (5................... porosity and pore-size distribution of (2.................................................................. 8....).............................................................................................................10................... 8........................................................... density of (2........................................ 1081 General Notices (1) apply to all monographs and other texts Index Sodium iodide (131I) capsules for diagnostic use .............. 3226 Sodium aluminium silicate........................ 3256 Sodium nitrite ....... 1086 Sodium iodohippurate (131I) injection ...........3–4408 Silica.........................12.... suspensions...)........ 3221 Simeticone .........6–5375 Sodium salicylate ..........................................................................) ..........................................................................................................1............................................................ 3262 Sodium propyl parahydroxybenzoate .......... 1082 Sodium iodide (131I) capsules for therapeutic use . 3236 Sodium carbonate monohydrate ......... 8........... 351 Sieving............................................................ concentrated. 8.............................. water for diluting. 3254 Sodium ethyl parahydroxybenzoate. 1088 Sodium molybdate dihydrate............................ 298 Single-dose preparations.............8........................................................... 903 Sodium acetate ([1-11C]) injection....7–5826 Sodium alendronate trihydrate . 3248 Sodium hydrogen carbonate ......)...................1............... 15 Sitagliptin phosphate monohydrate .7–5629 Sodium laurilsulfate ...................................................................................................................................................................... aluminium sodium...6–5382 Sodium perborate...) (5.................................... 8..................).........8....... 3230 Sodium benzoate ........................................) ........ 1079 Sodium citrate .... 8........................ 3271 Sodium tetrachloroaurate dihydrate for homoeopathic preparations ............................. 3270 Sodium sulfite heptahydrate................... colloidal anhydrous..................................................42.......................) ............... 8............... 68 Solids.... 1090 Sodium pertechnetate (99mTc) injection (non-fission) ................................................ 394 Silicone oil used as a lubricant (3................................. 3240 Sodium cyclamate.... 3235 Sodium carbonate decahydrate.............................7–5826 Sodium lauroylsarcosinate for external use... 8............... 3218 Silica............................................ characterisation of crystalline solids by (2...) ....................................................... aluminium magnesium....38........).. 272 Soluble tablets ......... oral .............. colloidal......................................................... 1524 Sodium amidotrizoate..............................17...... dissolution test for (2............ 8.....................2. emulsions and suspensions............ 8...).......4–4814 Sodium cromoglicate ...... 790 Solutions for haemodialysis..................)...................................... 8...................................................................................................................................................1....)...............................................5...................................................30................. recommendations on dissolution testing of (5......... low-substituted ... 3247 Sodium hyaluronate ...................... 8................................................................................................................................... 3271 Sodium valproate...............6–5175 Sodium caprylate .........) ... 3258 Sodium pertechnetate (99mTc) injection (fission) .. 323 Soft extracts ........6–5383 Sodium selenite pentahydrate .....................3............................ 8.......2–3897 Sildenafil citrate ...................................... 1129 Silver....................... dissolution test for (2.................. 3244 Sodium fluoride (18F) injection ..................38................. gas pycnometric density of (2...................................... 3222 Simvastatin ............................................................................. 3267 Sodium stearyl fumarate......................9......7–5829 Sodium starch glycolate (type B) (5.......... 780 Softening time determination of lipophilic suppositories (2. 8............................................. 3269 Sodium sulfate decahydrate...................................... 3272 Soft capsules ..................... 2378 Solutions for organ preservation ......)..................)......................................................5-hydrate ....................................................................... 1084 Sodium iodohippurate (123I) injection ............................................ 8........................................ 8.. 8....... 3263 Sodium risedronate 2.7–5629 Sodium starch glycolate (type A).23............... 1083 Sodium iodide (131I) solution ..............................9.............. 1087 Sodium iodohippurate dihydrate for radiopharmaceutical preparations ..................................... 1775 Sodium cetostearyl sulfate......... 8. 3254 Sodium methyl parahydroxybenzoate .............................. 8...7–5829 Sodium starch glycolate (type C).....................................7–5823 Sitagliptin tablets ...........................................................................................................................................................................................................................9................. cross-linked................................ analytical............. 1080 Sodium iodide (123I) solution for radiolabelling ...... 46 (S)-Lactic acid ............................ 8........ in distributor for veterinary use ..........................................................................................9...... 2994 Solutions.7–5620 SI (International System) units (1......3......................................... 811 Solution calorimetry and microcalorimetry............2–3984 Sodium thiosulfate...... 3258 Sodium phosphate (32P) injection......................6–5182 Siam benzoin tincture ................................................................. 305 Sieving................................................................ 3236 Sodium carboxymethylcellulose ........................................ ...... 1393 Stomata and stomatal index (2.........................1.......6.............. hydrogenated ......................................... intrauterine.......... 8........................... 3315 Streptomycin sulfate .....2...... 3302 Staphysagria for homoeopathic preparations ....................................... 1129 Streptokinase concentrated solution .......2....................................3–4254 Sophora flower-bud................. 1128 Sterile poly(ethylene terephthalate) suture in distributor for veterinary use.......................................................................) ..................2...5..... 3302 Stanozolol .........................................2................................... 418 Sterile linen thread in distributor for veterinary use ..................................................)............... sodium............................................................. reference (5.. 3303 Starch................ 3318 Sucralose ..................... 1117 Sterile catgut in distributor for veterinary use............................................. 40 Spectroscopy................................ 3305 Starch............................................................................. 607 Stavudine ............ control of impurities in (5.... 639 Solvents. 814 Sprays (liquid nasal) and drops (nasal)...... 3294 Spirapril hydrochloride monohydrate ........................... rice (5.............. 321 Sub-visible particles.. sterile non-absorbable.................................. John’s wort.................. ultraviolet and visible absorption (2........ 3322 See the information section on general monographs (cover pages) ................) ... particulate contamination (2..........................................................................9....................25...2................................................... 3275 Somatropin concentrated solution .......8....................................2....................................................... sodium (5.... 587 Sub-visible particles..........) ...........) .............)........ oromucosal drops and oromucosal sprays...3..... 139 Sticks . 3284 Sorbitol............................9... 793 St..................................................... 3283 Sorbitan trioleate .... 814 Squalane. 1681 Statistical analysis of results of biological assays and tests (5......5..........8...9...................6–5389 Sucrose monopalmitate............................. sodium (5....26......................................................................................... hydroxyethyl ........ 1399 Strands................................) ...................................19.. 1128 Sterile non-absorbable strands in distributor for veterinary use..................................23................................ 8..................................Index Solvents...............................1–3799 Starch.................. hydroxypropyl ............................. 3281 Sorbitan laurate.....) ..... infrared absorption (2........... 8........... 795 Substances for pharmaceutical use.... John’s wort dry extract................. 8......................... 1128 Sterile polyamide 6 suture in distributor for veterinary use...........7–5630 Sucrose ....................... 8......... 35 Spectrometry...................................................................)...) ................................ prepared ................................. 1394 Star anise oil ...............................7–5629 Starch glycolate (type A)..... 8................................................ X-ray fluorescence (2................1....................... 62 Spectroscopy............ wheat (5.............. methods of preparation (5.................. 1246 Sterile braided silk suture in distributor for veterinary use.....4–4815 Sorbitol........................... 8.........12.................................8............2................... 8........................................ 2419 Stephania root............................7–5630 Starflower (borage) oil......6................................................................................. 3279 Somatropin solution for injection ...... human haematopoietic .......................................................... 1129 Sterile non-absorbable sutures .............. 69 Spectrometry........................... 2684 Starch.............................................................3–4412 Starch.................... 38 Spectrophotometry..... 8........ 8........... 59 Spectrophotometry........ 8....................... 175 Sterility (2........................7–5598 Standards........3–4256 Sorbic acid ........2........................1......... 3078 Starch. 3289 Soya-bean oil............. 792 Sprays............................ 793 Sublingual tablets and buccal tablets.........................6–5386 Sophora flower ....... 8....................2..................... pregelatinised...........................1.............. 8....) (5..................................................................... 419 Sterile synthetic absorbable braided sutures ......... refined........... 8..... 3317 Strontium (89Sr) chloride injection................7–5620 Spectinomycin dihydrochloride pentahydrate........ wheat ............................................................................................................. 787 Sticks..............................) ..... 8.4.................7–5627 Starch................. 52 Spectrometry......... 765 Substances for pharmaceutical use.......... 8.................... 1391 St........ 1122 Sterile synthetic absorbable monofilament sutures ...........) .. residual (5.).............. 8...................19. 3563 Starch......................8.................................. 579 Spheroids and granules...... maize (5.............) .. 36 Spectrometry...9..............2............ residual.............4–4681 Stannous chloride dihydrate..........37.............. biological indicators (5................. nuclear magnetic resonance (2.......5....................................................................... 3287 Sotalol hydrochloride.......... liquid....................................................................40..33.....7 Starch........................ nasal .......................6–5208 Star anise.....................26...........4–4816 Sorbitol.... 3290 Spectinomycin sulfate tetrahydrate for veterinary use ........................8............... friability of (2......... 3290 Spanish sage oil .................) ...............................)..................... 8. 689 Substances of animal origin for the production of immunological veterinary medicinal products (5. 3306 Starch..............................................8....... pea .8.............. potato (5................. liquid (crystallising) ...................22...................... 1123 Sterilisation procedures.... in distributor for veterinary use ...........)....23............................................................................................................... veterinary .) (5.........................) .) ..)............................3........4................ 8..... 8...............................................4–4806 Starch.....) ... 1129 Sterile catgut...................... 3282 Sorbitan sesquioleate.8................................ application of the F0 concept (5.......................14..... 8.....2................. 560 Stearic acid (5............................... 556 Sterility (2. 1118 Sterile plastic containers for human blood and blood components (3..6–5387 Spironolactone ................................ 3314 Stearyl alcohol ................... maize .........................3–4413 Steam sterilisation of aqueous preparations...................................................................... sodium ......... 3319 Sucrose (5.................................48........7–5629 Stearic acid................................ 305 Specific surface area by gas adsorption (2...........................................................................) ...8. fourstamen .............24.. 3288 Soya-bean oil...7–5628 5880 EUROPEAN PHARMACOPOEIA 8...... liquid (non-crystallising) .............9.................................................................. atomic absorption (2................. mass (2...... rice ..2............ guidelines for using the test for (5.......) (5........................ 572 Sterols in fatty oils (2...................... hydroxypropyl..........1........................7–5618 Sterility........................................ 8..................................43....................................) .. 3283 Sorbitan stearate ..) ..................................... 8......7–5626 Starch..........) ......... 271 Stramonium leaf ..... atomic emission (2.. 8.......................................8.......................................) ............................................................) .................................... potato ............ 8.. 8.............................................................................................................................................4–4819 Stearoyl macrogolglycerides ...... 8..................................................................1........................... pregelatinised ..........7–5829 Starch glycolate (type B)............. 3314 Stem cells............... 809 Sticks...... 1129 Sterile products....1................................) ..................................3–4268 Subdivision of tablets ...........7–5620 Sucralfate .... 415 Sterile polyamide 6/6 suture in distributor for veterinary use...................................) .... 1092 Strychnos ignatii for homoeopathic preparations...7–5829 Starch glycolate (type C).. 3282 Sorbitan palmitate .................................................) ............. 8........................).............................4....)................) .......................... 8...................8................).9.....................................................................2...................................................)............................................................................................................ 809 Sublingual sprays............................ 329 Specific surface area by gas adsorption (2....................8..................9...... partially dehydrated .... 1397 Stramonium...........................................................................................1–3816 Somatropin ......24...........2.........7–5830 Sorbitol.......... 3277 Somatropin for injection . identification and control (2.................. 8................................................................. sodium.....) ..................................2..........4–4816 Standard solutions for limit tests (4................. 1390 Spiramycin............... quantified......................... 8............................................10........ refined ........................... 8... 3307 Starch glycolate (type A).................................................. 8.............7–5629 Starch glycolate (type B).....) ........................................................ near-infrared (2........3..................2................ Raman (2. 555 Sterile single-use plastic syringes (3........... 1389 Specific surface area by air permeability (2................................................ 359 Spike lavender oil.. 3282 Sorbitan oleate.....)................. 1127 Sterile containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution (3.............. particulate contamination (2.......................41.1......8...............................................) ............. 141 Somatostatin.......................................... 3292 Spectrometry..) ..........)..... 3298 Spot-on preparations................................................ 1395 Starches.........................) ..............7–5464 SPF chicken flocks for the production and quality control of vaccines (5..................2........................ ........5...... 8.......... 8.......................................................7 Sucrose stearate................................. 3364 Tannic acid ............... 3337 Sulfamethoxazole....... 814 Technetium (99mTc) bicisate injection ...............17.....................................................9............................................................................17........................................... 811 Tablets................)........... lipophilic. intrauterine....................................1.... 1095 Technetium (99mTc) etifenin injection.......... 807 Tablets.................................... 3361 Tamoxifen citrate .................. 8....7........................................ 3369 Temazepam.................................................... 1099 Technetium (99mTc) macrosalb injection ......7–5618 Sulfates (2..... 8..... 1019 Symbols and abbreviations (1..........4.................................................................................... 579 Test for anticomplementary activity of immunoglobulin (2................14................................................................................ 3345 Sulindac..................................7–5620 Test for Fc function of immunoglobulin (2......2............... 790 Suspensions......................................... 8.................................................9................................... disintegration of (2.................7..................................................) ............... 814 Tamsulosin hydrochloride..... 1172 Sumatriptan succinate...........................................................1.....................4..............................9...........................................................................................8........... 72 Suppositories ... 3326 Sugars...... refined ...................... rectal..6... 8....................................... 1123 Suxamethonium chloride ................................6–5139 Tablets ........9.................................................. 811 Tablets..........29........... 813 Tadalafil....... 200 Test for anti-D antibodies in human immunoglobulin (2.......... 3331 Sulfadimethoxine................................ 8.............................................................9..........13.......................................... 1100 Technetium (99mTc) mebrofenin injection ................. 132 Sulfathiazole ............... sterile single-use (3.............................................................. medicated ........... 787 Tablets.................................. 275 Tapped density and bulk density of powders (2..... 810 Tablets...... 215 Test for aristolochic acids in herbal drugs (2......................................8........................) ........................ effervescent......................... 419 Syrups............................. 782 Tampons............. 809 Tablets and capsules......................... 202 5881 ......... 1095 Technetium (99mTc) colloidal tin injection ............................................................ 1107 Technetium (99mTc) succimer injection.....) ........................... 1104 Technetium (99mTc) microspheres injection .............................10...............................................2....... 3344 Sulfur for homoeopathic preparations.... 3342 Sulfinpyrazone..................... 811 Tablets.6–5177 Technetium (99mTc) mertiatide injection ............................................. 3359 Talc ........ sterile synthetic absorbable braided .................... 3348 Sultamicillin tosilate dihydrate ............................... 1123 Syringes................................................... 8......... 1093 Technetium (99mTc) colloidal rhenium sulfide injection ........... 1108 Technetium (99mTc) tin pyrophosphate injection ... sterile non-absorbable ............................................ 279 Test for extractable volume of parenteral preparations (2.................. 8..................... 812 Tablets for vaginal solutions and suspensions ..) ........) .................................................................................................................................. softening time determination (2..............................................)................................................... friability of (2................)...... 246 Test for methanol and 2-propanol (2.... 3352 Sunflower oil............... disintegration of (2.......................................)... sterile .........7–5837 Tampons.................. 298 Tablets..8...........................) (5....... 3373 Terbinafine hydrochloride ....................26........................... lead in (2..................................)............. 1400 Swelling index (2.......................................7–5618 Tablets and powders for rectal solutions and suspensions .................) ................ 1122 Sutures............. 8...........2........................................ 810 Tablets............. 3375 Terbutaline sulfate .......... 811 Tablets.................. 1094 Technetium (99mTc) colloidal sulfur injection ....... 164 Sulfur for external use.................... 308 Test for extractable volume of parenteral preparations (2......................... 8..................................) ........................................... 807 Tampons....) (5......... 3355 Sweet fennel......................... 1018 Swine-fever vaccine (live..................................... 304 Test for neurovirulence of live virus vaccines (2............. 3345 Sulpiride.............................................................. 3366 Tannins in herbal drugs (2...........................) ................................................7–5679 Technetium (99mTc) pentetate injection ........................................................... sublingual ...............................................................................................................4............. 1122 Synthetic absorbable monofilament sutures.. 3343 Sulfur dioxide (2... prepared in cell cultures)..................... 8.................................. 3371 Tenosynovitis vaccine (live)........... avian ................................................................. 3339 Sulfanilamide.........9......8. 1401 Teat sprays ....................9..................... 795 Tablets..................... 3323 Sufentanil .......................................................... 787 Tablets for use in the mouth..... uncoated.. 3334 Sulfafurazole.8.............................................................................................. vaginal............9.................6–5391 Sulfadiazine ....14.... 795 Tablets.. 8...................................... 3367 Telmisartan....) ..................................................... orodispersible............................................................................................ medicated ................... 1101 Technetium (99mTc) medronate injection ..... 285 Tablets and capsules....... 8....................... plastic.. 806 Suppositories and pessaries...................................1.................................... friability of (2....5–5028 Sulfacetamide sodium ..................................... 3377 Terconazole........2...............................................................................................................................................17....................4.... 1456 Sulfuric acid........................9..................................................................................................................3–4417 Sulfadimethoxine sodium for veterinary use ................. 1109 Teicoplanin .......................................................................................... 3354 Suxibuzone ................... 1118 Sutures........... 8.....14..8................ vaginal............. 1106 Technetium (99mTc) sestamibi injection .........................8............................. soluble .................................34....................45.............. 791 T Table of physical characteristics of radionuclides mentioned in the European Pharmacopoeia (5.........................) (5..... 3335 Sulfamerazine....................... gastro-resistant..................... 3379 Terminology used in monographs on biological products (5.............................. dispersible.. 813 Tablets..... 1242 Sweet orange oil ...6....................................................... viral...........)..........1–3817 Sulfadoxine ............................................................................................ 809 Tablets.................................................................) ................... 1170 Sumatra benzoin tincture .3–4418 Sulfadimidine .......8............ sterile ........................... 811 General Notices (1) apply to all monographs and other texts Index Tablets.............................................5–4901 Tartaric acid.........................EUROPEAN PHARMACOPOEIA 8..... 8..................................... 287 Suppositories...22................. modified-release ............................................................................ 271 Swine erysipelas vaccine (inactivated) .............................) ..... chewable ...................... 3367 Teat dips........) .............) .........................................................2–3897 Synthetic absorbable braided sutures.................................................) ........... 323 Suspensions................................... 3354 Supercritical fluid chromatography (2............... 3340 Sulfasalazine ............ solutions..... 935 Tenoxicam ..............) ......................................1–3818 Sultamicillin ................18................ 8............................................................)....................9..............................................4.......................................................................... buccal ...................................8...............................7–5832 Sumatra benzoin .............. solutions and emulsions. 811 Tablets for intrauterine solutions and suspensions ............ 814 Tea tree oil .......................................................... 1105 Technetium (99mTc) oxidronate injection ...................................... 131 Sugar spheres.........9........ 299 Tablets............................................................................ 3378 Terfenadine........ ear ....7............. 1098 Technetium (99mTc) human albumin injection ..)...................).............................................. 811 Tablets... uncoated... oral .........................................6–5390 Sulbactam sodium ...........................................9........................6.............4–4701 Technetium (99mTc) exametazime injection ................. resistance to crushing (2....................................................... 3338 Sulfamethoxypyridazine for veterinary use................................... intrauterine................. 132 Sulfated ash (2.7.) ........ coated ........................ 3372 Terazosin hydrochloride dihydrate . subdivision of..................................... 3325 Sufentanil citrate ............... 8.....).................................................................................................................11... 812 Tampons..21) ................................... 3340 Sulfated ash (2............) (5.................... 8..............................................7–5620 Tablets........................................................................................... 3334 Sulfaguanidine ......... 1097 Technetium (99mTc) gluconate injection .) .................................. 3336 Sulfamethizole. 787 Sutures.................. classical ............ uncoated ................................................................................ sterile synthetic absorbable monofilament ............... disintegration of (2................... .......... diphtheria..... thymol type................ component).... 3450 See the information section on general monographs (cover pages) .......... 1407 Tosylchloramide sodium .9................... 840 Tetanus......................... human ...... poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) ........................................... ethyl and isopropyl) in active substances (2...7...34..... pertussis (acellular..... 826 Tetanus.) ............................................ reduced antigen(s) content) ............19............................. 827 Tetanus.................................... 8.....................) ............................8................... 3447 Tolterodine tartrate.... 165 Toxicity....... 202 Test for specified micro-organisms (microbiological examination of non-sterile products) (2... component) and poliomyelitis (inactivated) vaccine (adsorbed)...............1–3823 Tiaprofenic acid .................................................................................. 3416 Tianeptine sodium......... 3439 Tocopheryl hydrogen succinate............................... 8.............. 8........ voltametric (2........... 8....32.....6........................3–4233 Tetracaine hydrochloride..........................)............................................................. 3431 Titanium dioxide ........................8.....................) ............ hepatitis B (rDNA)........................................................................................ 158 Titration.......................... 8............ diphtheria and hepatitis B (rDNA) vaccine (adsorbed) ..............7–5661 Tragacanth .................................................................. 8................................ 3390 Tetracycline hydrochloride........................................... 8............................................. 8........ 1033 Tetanus antitoxin for veterinary use.... 3385 Testosterone propionate......................................... 3386 Tests for extraneous agents in viral vaccines for human use (2................................................................................... 3434 Tocopherol................... 3406 Thiopental sodium and sodium carbonate ............. 42 Thiocolchicoside crystallised from ethanol .................2............................................................. 844 Tetanus immunoglobulin.................................................. 242 Tetanus vaccine for veterinary use .............4–4823 Tobramycin.... 8................................................ 3396 Thermal analysis (2. 1407 Tormentil tincture .... pertussis (acellular..) ..................... 3393 Tetryzoline hydrochloride ...................6–5396 Thiamine nitrate ............................................... 3401 Thiamine hydrochloride ...................... pertussis (whole cell) and poliomyelitis (inactivated) vaccine (adsorbed) ..27. 3412 Thymol type thyme oil.....2–3970 Threonine .................................... 835 Tetanus....................................... 8.......................................................................................................................................................... component) and poliomyelitis (inactivated) vaccine (adsorbed..... 3387 Tetracosactide.....6............................................ reduced antigen(s) content)...........2............................................2.................6–5092 Thermogravimetry (2...............) (5...........................................................19......)................. 3436 Tocopherol.................................................... 3409 Thioridazine hydrochloride ................. names of herbal drugs used in (5..... 832 Tetanus.....................................................................................................7–5617 Thermal analysis (2..................2...... diphtheria and pertussis (whole cell) vaccine (adsorbed) .............2........................................ 3445 Tolfenamic acid .....). 3450 Total ash (2.....2–3951 Tetanus... 3446 Tolnaftate ......44...................................................... RRR-α-............. 261 Tetanus and diphtheria vaccine (adsorbed) .. diphtheria and pertussis (acellular.........33......................................13. 8..............................34............. diphtheria.........) .... component) and hepatitis B (rDNA) vaccine (adsorbed) ........................ poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) .....7................... 3411 Thyme ............. component) vaccine (adsorbed) ..................... 8.................... (Ramon assay) (2..........) ............ 8.............7–5838 Thiocolchicoside hydrate.....34........2–3971 Thyme oil................................................................ 8.................... poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed) .............. 830 Tetanus...... 3382 Testosterone enantate ..... 1406 Toluenesulfonate (methyl...... wild....).............................................................. assay of (2.............4–4501 Torasemide......................................... 3438 α-Tocopheryl acetate concentrate (powder form)............................................................... 8..... diphtheria....................................... 8........... abnormal (2................................).....................................40...2.13...)........) (5.......................................... 3430 Tiotropium bromide monohydrate ... 3410 Thomson kudzuvine root ..... 3423 Tick-borne encephalitis vaccine (inactivated) .................)..................................................................................................................................... 8. pertussis (acellular........................................................................... 3449 Tormentil ....................................)...... flocculation value (Lf) of..... 3437 Tocopheryl acetate................................................................................................................ 842 Tetanus......6............... 907 Tetanus vaccine (adsorbed)................................8........................ 8................................................................ 908 Ticlopidine hydrochloride ..................... diphtheria and pertussis (acellular............................ 3441 Tocopheryl acetate..................................................... 8.......... 825 Tetanus....................65.................................................2.............................................................).............................2................ 8...........7–5617 Thermogravimetry (2.... 3413 Tiamulin for veterinary use.......5..........................................6–5091 Titration..6–5395 Theophylline monohydrate ................6................................. 1402 Three-lobed sage leaf ............................................... 8................... 8.......................) (5.............. 3433 Titration.7–5618 Testosterone................... anhydrous ..............3–4221 Tetanus antitoxin for human use ...... component)........... 3391 Tetra-O-acetyl-mannose triflate for radiopharmaceutical preparations ........................... 8.............................................................2–3974 Thymol........ 132 Total cholesterol in oils rich in omega-3 acids (2....................... 71 Total protein (2....................... 3395 Theophylline-ethylenediamine....... diphtheria and poliomyelitis (inactivated) vaccine (adsorbed. component) vaccine (adsorbed............. 198 Tetanus and diphtheria toxins and toxoids.............6............................... 8........ RRR-α.......34....... 109 Tizanidine hydrochloride ...........).................Index Test for neurovirulence of poliomyelitis vaccine (oral) (2............................ 823 Tetanus and diphtheria vaccine (adsorbed........................4..............6–5399 Thin-layer chromatography (2............ 3388 Tetracycline .............................. 3443 Tolbutamide.............................................. 189 Test for specified micro-organisms (microbiological examination of non-sterile products) (2............................11.......... diphtheria.............................................................. all-rac-α..........................6–5398 Thiamphenicol .......... 829 Tetanus...................................................................... 8.................................) ......................... 1040 Tetanus........................ 1111 Theobromine...... pertussis (acellular....................................22........................ 3407 Thioridazine .............................................................. anhydrous.............. 1405 Thyme....16................................... 184 Traditional Chinese medicine............ 3426 Timolol maleate ............................................) ................... DL-α.8........................................... amperometric (2. 8........... 3420 Tibolone....................................................... 3380 Testosterone decanoate ........................................ pertussis (acellular..... diphtheria................. pertussis (whole cell)............ 1110 Tetrazepam .................................7–5840 Thioctic acid.............................................. diphtheria.........................5..........................3–4423 Theophylline ............ complexometric (2.... 834 Tetanus....................................... 3427 Tinctures .........................................) .......27........... 3414 Tiamulin hydrogen fumarate for veterinary use............... component) and haemophilus type b conjugate vaccine (adsorbed) ..................................... 3405 Thiomersal........................................... 3383 Testosterone isocaproate .............................4–4824 Tolu balsam ...............................................................................16............................................) ..................................... all-rac-α-............5.................................3–4253 Tinzaparin sodium ........... 1405 Tiabendazole ..................3–4357 Tetanus vaccine (adsorbed) ...............................4..................................... 3418 Tiapride hydrochloride ... 3424 Tilidine hydrochloride hemihydrate .. RRR-α-..........2.....................7 Thiamazole ..... 3430 Tioconazole ....................6–5091 Titrations............................6–5092 5882 EUROPEAN PHARMACOPOEIA 8........ reduced antigen(s) content)............... diphtheria........................... diphtheria............................................ 8.......................................................... 1408 Tramadol hydrochloride ................................. pertussis (acellular.............) ............... reduced antigen(s) content).... 151 Total organic carbon in water for pharmaceutical use (2........ potentiometric (2........................................................................... 8............................................................5–4916 Tinidazole ................................. 3398 Theophylline-ethylenediamine hydrate ........................... 3421 Ticarcillin sodium ...................................... 3394 Thallous (201Tl) chloride injection .. 3429 Tinnevelly senna pods.....................20........................................) ............................................ 837 Tetanus........ 3442 Tocopheryl hydrogen succinate.............................. .................................5......) ....... omega-3-acid .. 8.................. polysaccharide................... ribose in (2....... oral..........................2–3974 Valerian root....... viral..........7 Tramazoline hydrochloride monohydrate.........5.................. 159 Vaccines.................................................................. 8................ 202 Vaginal capsules ................ 3483 Tropisetron hydrochloride........) ................................................................ tablets for.. 17 Tubing and closures.........17..........) .................2.......................... conjugated polysaccharide.........................13. 160 Vaccines.............. 592 TSE............9....2......................................... 1416 5883 ......................................................5.................9.......6–5401 Tryptophan ..... 3474 Trimeprazine hemitartrate ............................. freeze-dried ......................... 3456 Tretinoin ....... 394 Tubing and containers for total parenteral nutrition preparations.......................................................... 3473 Trimebutine maleate .) ..............7..............6–5133 Vaccines..... 3463 Tribenoside............22........................................................... methylpentoses in (2............................. 3481 Trometamol ....23..................................5........................... 3502 General Notices (1) apply to all monographs and other texts Index U Ubidecarenone ........................ hydrated ... 3517 Valaciclovir hydrochloride................................................. cut .........................) .5–4929 Tyrosine .......... 3488 Trypsin ... 8.......) ...................................................................................... 3497 Tylosin phosphate bulk solution for veterinary use .... 8.......... 759 Tuberculin for human use............. 160 Vaccines..9..................)......... evaluation of efficacy of (5........ 770 Vaccines.. 161 Vaccines...... polysaccharide..............20...5–4957 Valerian root.................................... freeze-dried................... 3470 Triglycerides..................................................9. veterinary..................... 8................................. emulsions and suspensions................. 3492 Tuberculin purified protein derivative............. test for neurovirulence (2...............................11........ polysaccharide......... 3466 Trichloroacetic acid ........ 159 Vaccines and immunosera............ strain Ty 21a) ..... minimising the risk of transmitting via human and veterinary medicinal products (5........)...... sialic acid in (2..........................................................2..............5–5033 Triethanolamine.............3–4258 Turmeric rhizome.. 591 Vaccines and immunosera.....) ...................................5.......................16................ polysaccharide.7–5620 Uniformity of dosage units (2...............................1....)....................2–4105 Tyrothricin............................... calcium in (2......................) ......2–3991 V Vaccines............................... 579 Vaccines........... 813 Vaginal foams...... hexosamines in (2..) ..................14................................) .... 161 Vaccines..........)..... 3507 Udder-washes..........).........2–3897 Unsaponifiable matter (2........................... 8............ medium-chain .........2.................................................................................................................... phosphorus in (2..................5....................................................21........................................... anhydrous ............... 8................... 3454 Transdermal patches ....................... animal...................... 3452 Trandolapril..................2–3973 Tylosin for veterinary use ................. 8... silicone elastomer for (3.................. polysaccharide..........................................................................................................4....................................... medicated . 3468 Trifluoperazine hydrochloride ............................................................ poly(ethylene .........................5–4921 Typhoid polysaccharide vaccine ............ 157 Urea ............................. 40 Ultraviolet ray lamps for analytical purposes (2. 812 Vaginal preparations.........5............................ 3509 Urokinase.... 3510 Uronic acids in polysaccharide vaccines (2.............................................. 161 Ursodeoxycholic acid ...................1–3669 Uniformity of mass of delivered doses from multidose containers (2........................................ 1504 Trimetazidine dihydrochloride ..................................... semi-solid ..... 3467 Tritiated (3H) water injection .............................7–5843 Tri-n-butyl phosphate .....2......................)....... 8................................................. carrier proteins for the production of (5......... cell substrates for the production of (5..2........... 819 Tubes for comparative tests (2................ adsorbed) vaccine . 160 Vaccines................ polysaccharide.......... 3475 Trimethadione.. 911 Typhoid vaccine (live.............27....... bovine .... 3483 Tropicamide...............................................................1.................5...........).............................................5........................................) ..................................... 3453 Tranexamic acid............ 8..................................9............. 160 Vaccines................... polysaccharide.31.............................). 3469 Triflusal ................................ 8......................... 15 Uncoated tablets .......... 8.........) .... polysaccharide................................................................) ...................................... protein in (2.................. 813 Vaginal tampons....5..... 1022 Turmeric......................................... O-acetyl in (2.............. aluminium in (2..............................................................................) (5....) ...1..16.9...........................................3....) ............................1.............................................................................................. uronic acids in (2................................. 810 Undecylenic acid................ nucleic acids in (2....................................... polysaccharide......................................... 3472 Trihexyphenidyl hydrochloride ......47............. 164 Vaccines...................... phenol in (2...... 3455 Trehalose dihydrate .........) .................7.................. viral live............................................................. 3471 Triglycerides..... 8.........................................2........ 3494 Tuberculin purified protein derivative for human use.............) ........18................EUROPEAN PHARMACOPOEIA 8.....................vinyl acetate) for (3.................5.22................................. 813 Vaginal solutions........................... 582 Vaccines for human use............ 3493 Tuberculin purified protein derivative.................9...... 588 Vaccines for human use .... adsorbed..................).....3–4423 TSE....................... 295 Trapidil............... 3500 Typhoid polysaccharide and hepatitis A (inactivated.... 161 Vaccines.. 3459 Triamcinolone ...........2............ evaluation of safety (5........) ..........5................................................40........18............... 8................6.............. 198 Vaccines for veterinary use................... animal............................. 8................................................)............. 3460 Triamcinolone hexacetonide ... 814 Ultraviolet and visible absorption spectrophotometry (2.....................................2...........19......) ....) ...................................... 813 Vaginal preparations ........................ 159 Vaccines and immunosera............5. SPF chicken flocks for the production and quality control of (5..... 767 Vaccines for human use.......25............ tests for extraneous agents in (2.... 297 Units of the International System (SI) used in the Pharmacopoeia and equivalence with other units (1.......... 3512 Urtica dioica for homoeopathic preparations........................ 298 Uniformity of dosage units (2............................ 8.....................) .......... cell cultures for the production of (5....... 813 Vaginal solutions and suspensions............) ................................................................................................ 8.. 3485 Trospium chloride .............................................5........5..... 8.............. 911 Typhoid vaccine................................. 3508 Urofollitropin ................)................................. 3462 Triamterene ................4..2–4109 Valerian dry aqueous extract ...8................. 8................3–4259 Turpentine oil............................ 331 Uniformity of mass of single-dose preparations (2................................................. 3495 Tuberculosis (BCG) vaccine.......................) ............................................. 3458 Triacetin .........3–4205 Vaccines for human use...................... 391 Tubing used in sets for the transfusion of blood and blood components..................................... avian ................ 3459 Triamcinolone acetonide ...................................... demonstration using large sample sizes (2...... 1111 Trolamine.......2.... 3508 Uniformity of content of single-dose preparations (2..........................................7....................................... 813 Vaginal tablets ............6–5400 Tributyl acetylcitrate........................ 8......)................6................ products with risk of transmitting agents of........................4–4513 Turkey infectious rhinotracheitis vaccine (live) ........................3....................................... 3477 Trimipramine maleate..........1............................. 8........... veterinary....6........9. 1412 Valerian dry hydroalcoholic extract ....................................... 2909 Triglycerol diisostearate ..........................................................................1... adsorbed..................5–4958 Valerian tincture .40..... veterinary...............................................15.............................................................................. 3498 Tylosin tartrate for veterinary use ........................................ 8........8.......................................7–5674 Typhoid vaccine ........................... 798 Transdermal patches.... 3481 Triethyl citrate............... dissolution test for (2....................) ........ 3486 Troxerutin... old......................... 159 Vaccines.. 8...5.............................................. 3476 Trimethoprim.. 8.........6–5123 Uniformity of dosage units............ materials based on plasticised poly(vinyl chloride) for (3... 3468 Triclabendazole for veterinary use ................... 814 Valaciclovir hydrochloride......6...... Javanese..) . ............................................. 3532 Verbena herb ....................... 3595 See the information section on general monographs (cover pages) ... 163 Water : micro determination (2...............................) ....... 8...2................................................... 2435 von Willebrand factor......................................................1–3829 Warfarin sodium clathrate....8............................................... 3525 Vanillin........... 8........ substances of animal origin for the production of (5.... 1422 Willow bark dry extract ............................... 3580 Y Yarrow ... particulate contamination (2............) ......... 8..... 3539 Vinpocetine ....................................... immunological............................. 8............................)........................................ 3272 Valproic acid..... characterisation of crystalline and partially crystalline solids by (2...........1–3689 Veterinary vaccines and immunosera.................... 3579 Xylose ......... 1112 Water............29............................... 964 Viral rhinotracheitis vaccine (inactivated).................................................................................... 263 Vibriosis (cold-water) vaccine (inactivated) for salmonids........... 3536 Vindesine sulfate.........20.. bacterial cells used for the manufacture of............. 3537 Vinorelbine tartrate . 8...16....... nucleated cell count and (2................................ 914 Yellow soft paraffin........2–4115 Zinc acetate dihydrate ........... 3575 Xenon (133Xe) injection ................................ 3529 Vegetable fatty oils .......... 3564 Wool fat... 935 Viral vaccines for human use......... 85 Viscose wadding........ 591 Viability...... 801 Vardenafil hydrochloride trihydrate.............5...................................................25................................................................................................. refined..... 3591 Zinc chloride ..... 706 Vectors for human use....2............................... 1024 VICH (5....... 3594 Zinc sulfate heptahydrate ............. 271 Water in gases (2............................ 198 Viscometer method.........37...............................1................................... human ... 353 Wettability of porous solids including powders (2.............................................................................................7–5608 Volumetric solutions (4...........)......................................) . synthetic ..65......................... 3559 Water in essential oils (2.)...... 3555 Water for pharmaceutical use............................................................... plasmid.......................................................2...8........................................................................................... 3569 Wool fat................................................... avian .......................... 3564 Wheat starch........) .................... 710 Vecuronium bromide .............3–4434 Xylometazoline hydrochloride.................. 3521 Valproate...........)................... poxvirus ... 3563 Wheat starch (5........................................................... absorbent .................. 977 Viral safety (5.....1–3830 Washes..... 3561 Water : semi-micro determination (2............................................... 109 Volumetric analysis (4..... 1630 White horehound ....2–4111 Varicella immunoglobulin for intravenous administration....... 2434 Varicella immunoglobulin...2–3921 Validation of nucleic acid amplification techniques for the detection of hepatitis C virus (HCV) RNA in plasma pools : guidelines.................39) ......................... 31 Water for diluting concentrated haemodialysis solutions.............................. 3534 Vinblastine sulfate .........................).. 793 Water (15O) injection ..................... 3593 Zinc oxide ... human..... 8..13................................. European .............9.....1...........2.......................... 27 Viscometer method... 976 Viral rhinotracheitis vaccine (live)...... evaluation of efficacy of (5.................................................................... 40 Visible particles.....21....... mumps and rubella vaccine (live)..................................7.......................................................................................................................... 1417 Veterinary liquid preparations for cutaneous application..........).........................................................7 von Willebrand factor.............................................. 8...................................................................................................)......................................... 2966 Wild pansy (flowering aerial parts)....................... 571 Viral tenosynovitis vaccine (live)........................................................................................................................) ......4–4829 Zidovudine ............................................. determination by distillation (2................ human...............................2...................................................) .......2–3921 Valine ..................................3–4359 Varicella...... 3535 Vincristine sulfate...................... 814 Veterinary medicinal products...........................................10............2................... duck ... 3548 W Warfarin sodium.......8....................... 3527 Vapour......................................) ........................ 1033 Viral diarrhoea vaccine (inactivated).................... nasal........... 1420 Wild thyme.........) . 2967 Yersiniosis vaccine (inactivated) for salmonids ........................................... 323 Vitamin A ..................................... 913 Vectors for human use.... 1419 White soft paraffin.....7..............6–5105 Water.................................. hydrous............................................................................................................................ 3546 Vitamin A concentrate (solubilisate/emulsion)...................2.................................................7–5609 Volumetric solutions............32............................... 3565 Wool fat.................................. bovine .......) ..........................................12......2.. 8..28..................... 707 Vectors for human use.................................... 3592 Zinc gluconate.............................................................2–3974 Willow bark ....... 8........................ 3570 Wormwood................................................................ 3523 Valsartan .... purified ... 3594 Zinc stearate ..... sodium.....2. 71 Water for preparation of extracts..........................9....... 1113 X-ray fluorescence spectrometry (2............................. 708 Vectors for human use...9................... 1630 Yellow fever vaccine (live) ........ tests for extraneous agents in (2. synthetic................ 8.................................................................................................. 8........................................) ...... 587 Veterinary semi-solid preparations for oral use .................) .................... 3558 Water................. highly purified .......................................................7................... 3541 Viper venom antiserum...........................5....................... virgin....................................................................... 3545 Vitamin A concentrate (powder form)...................... 8......................................... 8............................ 8...........7–5617 Vigabatrin ........ human ................. 3547 Voltametric titration (2...............................................) .............................................................................................2....... 8.... measles................................2........................ capillary (2................................................. 3524 Vancomycin hydrochloride .......................................................... 3595 Zinc sulfate hexahydrate ............................ synthetic .................7–5630 White beeswax ........ 3530 Verapamil hydrochloride .........................................) ............................. 3585 Z Zanamivir hydrate ................................................... 257 Voriconazole..................................) ............................................. 1025 Yohimbine hydrochloride .................................................................................5....................................... 1424 X Xanthan gum............... 3590 Zinc acexamate ......................... hydrogenated........9..............9............44.... adenovirus ................................ 775 Venlafaxine hydrochloride ....5................................ 8.............................. 3544 Vitamin A concentrate (oily form)................................ 941 Viral hepatitis type I vaccine (live)............................Index Validation of nucleic acid amplification techniques for the detection of B19 virus (B19V) DNA in plasma pools : guidelines...) .... falling ball (2.............8......................2.........3–4429 Valnemulin hydrochloride for veterinary use ...............................................45..............2–3976 Yellow beeswax...........................) ....... plasmid ...........................................) ...............................................................2.......2..... 1023 Vibriosis vaccine (inactivated) for salmonids ...........................................33.... 8.................................................. 3542 Viscosity (2..... 28 Visible and ultraviolet absorption spectrophotometry (2.... 8.... 8........................................7............ 2375 Water for injections .............................)....................... feline .... 3563 Wheat-germ oil........................................................... preparations to be converted into.............3–4433 Xylitol .. 8................. 1423 Wool alcohols ......2.......................................... feline ...........................................................................................) .............................................................................. 59 X-ray powder diffraction (XRPD)............ 873 Varicella vaccine (live) .....................................................5................................................................ total organic carbon in (2...................7–5608 5884 EUROPEAN PHARMACOPOEIA 8...............49................... 8..rotating viscometer method (2.................... 339 Xylazine hydrochloride for veterinary use .......... assay of (2............ primary standards for (4....6............. 27 Viscosity .......................................) ...............5–4891 Water-solid interactions: determination of sorptiondesorption isotherms and of water activity (2.... 365 Wheat-germ oil.................................... 3528 Vedaprofen for veterinary use.................... ..................................................... 3600 Zoster (shingles) vaccine (live).......................................................................................7 Zinc sulfate monohydrate........................ 3601 5885 .....7–5847 General Notices (1) apply to all monographs and other texts Index Zolpidem tartrate.............. 8......................... 3596 Ziprasidone hydrochloride monohydrate........... 8...EUROPEAN PHARMACOPOEIA 8..................... 3598 Zopiclone ... herpes.......................... 902 Zuclopenthixol decanoate.......................................................................................................................... 3595 Zinc undecylenate ...........3–4439 Ziprasidone mesilate trihydrate ............. EUROPEAN PHARMACOPOEIA 8.7 5886 See the information section on general monographs (cover pages) . ......................... 1505 Acidum maleicum ........................ 1139 Acidum aminocaproicum..................................................................................................................................................................................... 3508 Acamprosatum calcicum .................................. 2898 Alteplasum ad iniectabile .......................................................... 8................5–4991 Acidum citricum monohydricum ........................................ 8................................................ 2849 Alprazolamum................................................................. 1136 1:2 .............................................................................................. 1511 Acidum nitricum.....................................................................6–5351 Althaeae folium ............................. 3446 Absinthii herba ................................................................................................................................................................... 1594 Alcohol cetylicus ........................................................................................................................................................................................................................................................................................................................................................................................................................................................................................ 3314 Acidum etacrynicum..................................................................... 2344 Alfentanili hydrochloridum ............................................................................................................................................. 1522 General Notices (1) apply to all monographs and other texts 5887 .................................................... 2438 Alimemazini hemitartras ................................................................................................. 1521 Acidum (S)-lacticum.. 8............................................................................................... 3420 Abacaviri sulfas ............................................................................................................. 1524 Acidum sorbicum ..................................................................................................................................................................................................................................................... 1141 Acidum mefenamicum ......... 8..................2–3995 Acidum adipicum............................ 3454 Acaciae gummi ................................................................ 8.... 1473 Adeps lanae hydrogenatus.............5–4941 Acidum trichloraceticum .......................................................... 2386 β-Acetyldigoxinum...........................................................6–5306 Allantoinum............... 2428 Acidum sulfuricum ........................ 2185 1:1 ........... 1424 Acidum tranexamicum......................................................... 2579 Aluminii natrii silicas ............................................................................ 1497 Acidum folicum .................. 3025 Alumen................................................................................................... 2701 Aloes extractum siccum normatum........................................................6–5341 Alprostadilum........................ 1487 Acemetacinum ......... 1682 Alcohol cetylicus et stearylicus emulsificans A ................................................................................................................................................... 1477 Alaninum ....... 3523 Acarbosum .......................... 8....7–5699 Aluminii chloridum hexahydricum..... 1472 Adeps lanae cum aqua...................................... 1837 Acidum benzoicum ............................ 2685 Almagatum ................................. 1469 Adeps A 3-O-desacyl-4-monophosphorylatus ............................................................................................................ 1467 Adenosinum................................... 1254 Acidum lacticum ...................................................................................... 3570 Acetylcholini chloridum.............6–5306 Allii sativi bulbi pulvis..................................................................................................................................................................................................................... 1461 Acidum ursodeoxycholicum .................. 2730 Agni casti fructus.............. 1501 Acidum hydrochloridum concentratum.................................... 1519 Acidum pipemidicum trihydricum..................................................... 3198 Aluminii magnesii silicas........ 2128 Alcohol stearylicus......................................................3–4238 Acidum medronicum ad radiopharmaceutica ................................1–3734 Acidum caprylicum ............................. 1509 Acidum niflumicum....................... 1484 Acebutololi hydrochloridum........................... 1540 Alcohol 2............................... 8........................ 1507 Acidum malicum.............. 2185 Acidi methacrylici et methylis methacrylatis polymerisatum Aether anaestheticus ................................. 8.. 8........................................................................................... 3564 Acidum citricum anhydricum...................... 3468 Acaciae gummi dispersione desiccatum . 3405 A Acidum tiaprofenicum...............................4–4819 Numerics α-1-Proteinasi inhibitor humanum ............................................................6–5213 Alchemillae herba.................................................................... 2729 Aetherolea ......................................... 2404 Acidum amidotrizoicum dihydricum ..................... 1460 Acidum undecylenicum ....... 3345 Acidum tartaricum .......................................... 1504 Acidum iopanoicum....................4–4709 Acidum oleicum ........ 2728 Aer medicinalis artificiosus .................................... 8.....................................1–3737 Alcohol oleicus ................................................. 1496 Acidum alginicum................................ 2899 Acidum edeticum ......................7 Index Acidum stearicum ...... 3038 Aluminii hydroxidum hydricum ad adsorptionem ...... 8............................................. 1515 Acidum oxolinicum........................................................................ 2578 Allium sativum ad praeparationes homoeopathicas.................................................... 8........ 1756 Alcohol cetylicus et stearylicus emulsificans B ........................ 1590 Alcohol benzylicus ........................................................................................ 1466 Adeninum ............. 1136 Acidum valproicum .. 3281 Aluminii oxidum hydricum .............. 8................................................................................................................................................................................................................... 1489 Albendazolum...................... 1072 Aloe capensis.............................. 1494 Acidi methacrylici et ethylis acrylatis polymerisatum 1:1 ................. 1473 Adeps solidus .............................................................................................................. 3367 Acidum thiocticum....... 1833 Acidum boricum........................................................5–4965 Acidum glutamicum ...................... 1840 Alcoholes adipis lanae...............................................................................................................................................1–3736 Alcohol isopropylicus ................... 1645 Acidum asparticum.............................................................. 1310 Acidum phosphoricum concentratum .................................................................................................... 8.................................................................................................5–4963 Acitretinum........... 1505 Acidum ioxaglicum ..................................................................................1–3735 Acidum chenodeoxycholicum....................... 1470 Adeps lanae...........................3–4238 Acidum aceticum glaciale...................................................... 1643 Alcohol cetylicus et stearylicus ................................... 8.......................................... 1519 Acidum picricum ad praeparationes homoeopathicas. 2851 Alprenololi hydrochloridum.............. 2310 Alfadexum................................ 1502 Acidum hydrochloridum dilutum ...................... 1539 Agni casti fructus extractum siccum .................................................. 1520 Acidum salicylicum..............................................................................................................3–4275 Agrimoniae herba ....................................................................................................................................................................... 1475 Adrenalini tartras .... 3025 Altizidum .................. 2727 Aether ........................................... 3565 Acetonum ........................................... 1490 Acidi methacrylici et ethylis acrylatis polymerisati 1:1 dispersio Aer medicinalis.......................... 2283 Alfacalcidolum..................................................................4-dichlorobenzylicus ............ 743 Acidi methacrylici et methylis methacrylatis polymerisatum Agar .................................................... 1518 Acidum phosphoricum dilutum................................ 2177 Alcuronii chloridum......2–3981 Acidum lactobionicum ...................................................................................................................................3–4237 Acidum 4-aminobenzoicum.................. 2686 Aloe barbadensis ..........1–3745 Acidum ascorbicum .................................................................................................. 2956 Althaeae radix ..................................... 8.......................................................................... 8.............. 1045 Acidum nicotinicum ................................... 8........EUROPEAN PHARMACOPOEIA 8.............. 3569 Acetylcysteinum..................................................... 2000 Acetazolamidum ............................................................................................................................. 3512 Acanthopanacis gracilistyli cortex ..1–3719 Acidum tolfenamicum ....... 8......................... 8..................................................................... 1485 Aceclofenacum...... 8................................................................................................................................ 1464 Adapalenum ......... 2581 Allopurinolum ............................................................................................. 1498 Acidum fusidicum ....... 8......................................... 1138 Acidum acetylsalicylicum ............................................. 1482 Adrenalinum .......................... 1503 Albumini humani solutio .... 1309 Acidum palmiticum ........ 8.......................................................................3–4239 Acidum nalidixicum .................. 1491 Aciclovirum......................... 1492 30 per centum ................................... 2438 Alfuzosini hydrochloridum ........................7–5787 Alovudini (18F) solutio iniectabilis........................................................... 1487 Acesulfamum kalicum ..................................................................................................................... 8......................................... 8..................... 8................................................................... ............. 2375 Aqua ad extracta praeparanda................................................................6–5213 Aluminii phosphatis liquamen.. 1610 B Bacampicillini hydrochloridum ...................................................... 1544 Amitriptylini hydrochloridum ......... 3555 Aquae (15O) solutio iniectabilis ....................................................................... 8............. 8..1–3722 Arnicae flos ................................................................... 3558 Aqua ad iniectabile ................................... 1557 Amphotericinum B................................ 1596 Atorvastatinum calcicum trihydricum. 1641 Benzocainum ....................... 8.............................. 8........................................................................................................................7 Argentum colloidale ad usum externum........................................ 1593 Astragali mongholici radix ....................... 1171 See the information section on general monographs (cover pages) ........................................7–5707 Azithromycinum ...................................... 1185 Balsamum peruvianum ................................................ 8........... 1151 Arnicae tinctura .............................................................................................................................. 1163 Belladonnae folii extractum siccum normatum. 753 Antithrombinum III humanum densatum.................................................................................. 1638 Benzalkonii chloridum ............................................. 1570 Anemarrhenae asphodeloides rhizoma ........................................ 1541 Amiodaroni hydrochloridum ... 1624 BCG ad immunocurationem................................................................................................................................ 1617 Bacitracinum zincum...................................................................................................... 8.......3–4264 Amantadini hydrochloridum ........................ 1508 Amygdalae oleum virginale........ 8................................................. 1554 Amomi fructus........................................... 8................................................................... 1168 Benazeprili hydrochloridum ................................................. 1636 Benzalkonii chloridi solutio........................................................................... 3305 Amylum pregelificatum ...........1–3701 Amomi fructus rotundus ............................................2–4002 Argininum........................................................................................................... 1566 Amygdalae oleum raffinatum ....... 1181 Aurantii dulcis aetheroleum ..... 1622 Barbitalum..................................... 8...............................................................3–4266 Anastrozolum .............................................................................................................................................................. 8.................................... 1568 Amylum hydroxypropylum ........................................................................................... 1170 Benzoe tonkinensis ........ 1553 Ammonio methacrylatis copolymerum A .................................................7–5684 Aurantii amari epicarpii et mesocarpii tinctura........ 1167 Belladonnae folium ..................................................... 1549 Ammonio methacrylatis copolymerum B .. 8... 1522 Aluminii stearas ...........................................3–4275 Amyla hydroxyethyla.............................................................................................................................................................................................................................................. 8............................................. 1529 Amfetamini sulfas ................................................... 8...... 781 Azaperonum ad usum veterinarium.........................................................6–5182 Benzois sumatrani tinctura ...................................... 1147 Anisi aetheroleum ................................................................................................................... 1621 Ballotae nigrae herba ................ 1637 Benzbromaronum .................6–5215 Aminoglutethimidum ... 8............................................... 1619 Baclofenum ............................ 1552 Ammonii hydrogenocarbonas............................ 8................................................................................ 8....................................................................................................... 1640 Benzethonii chloridum...........................5–4945 Belladonnae folii tinctura normata............................................................ 818 Beclometasoni dipropionas anhydricus......................................................................................... 1608 Azelastini hydrochloridum............................................ 1605 Atropinum ............ 1528 Ambroxoli hydrochloridum....................................................................... 3303 Amylum hydroxypropylum pregelificatum.. 1571 Anticorpora monoclonalia ad usum humanum ....... 1591 Asparaginum monohydricum ...................................................................................... 1635 Bentonitum .............................................................................7–5683 Angelicae archangelicae radix...................... 1555 Amoxicillinum trihydricum ..........................2–3983 Articaini hydrochloridum .............................................................2–4001 Argon .......... 1150 Anisi stellati aetheroleum ......................... 1633 Benserazidi hydrochloridum ... 1145 Angelicae sinensis radix...................................................... 8.................................................. 1047 Ammoniae solutio concentrata .................... 8. 1586 Arginini hydrochloridum ................................ 1142 Angelicae dahuricae radix............................................ 1561 Ampicillinum natricum ................................ 8... 1595 Atomoxetini hydrochloridum ...........................................7–5703 Ammoniae (13N) solutio iniectabilis ..................... 1578 Aprotinini solutio concentrata . 8............................... 1400 Auricularia .......5–4942 Angelicae pubescentis radix................................................................................. 1587 Aripiprazolum .................... 1153 Arsenii trioxidum ad praeparationes homoeopathicas ....... 1604 Aucklandiae radix.................................... 3559 Arachidis oleum hydrogenatum...................................... 3306 Anamirta cocculus ad praeparationes homoeopathicas .................................. 8.............................................5–4946 Aurantii amari flos ............... 8............................ 1584 Arachidis oleum raffinatum .............................................................................................................2–3998 Amikacinum ........ 3561 Aqua valde purificata ......................5–4966 Ascorbylis palmitas ................. 8............. 1552 Ammonii glycyrrhizas............. 1628 Belamcandae chinensis rhizoma...... 1395 Anisi stellati fructus .............................................................................................................................6–5220 Aqua ad dilutionem solutionum concentratarum ad haemodialysim ..................................... 8... 1172 Benzois tonkinensis tinctura .............................................................................................................................................................................................................................. 1631 Bendroflumethiazidum.................. 1542 Amisulpridum ..................................................................................................................................................... 1546 Amlodipini besilas..................................................... 8.......... 1159 Atractylodis macrocephalae rhizoma ........................ 3307 Amylmetacresolum.................................................................................................. 1527 Alverini citras ............................ 1548 Ammonii bromidum ................................................ 3221 5888 EUROPEAN PHARMACOPOEIA 8........................ 1623 Barii chloridum dihydricum ad praeparationes homoeopathicas ......................................................... 1592 Aspartamum............................... 8..................................................................................................................................................... 1633 Benperidolum .............................2–3996 Amiloridi hydrochloridum dihydricum ........................................ 1394 Antazolini hydrochloridum...................................6–5206 Atropini sulfas .............. 1527 Amanita phalloides ad praeparationes homoeopathicas ...................................................................................................................................................... 1564 Ampicillinum trihydricum ..................................................... 1531 Amikacini sulfas .............................................. 1406 Bambuteroli hydrochloridum .......................................................6–5223 Aprotininum ............................................................... 8................................................................................ 1554 Amobarbitalum natricum .......................................................................................................................... 1354 Balsamum tolutanum.............5–4971 Benzoe sumatranus ....2–3983 Apomorphini hydrochloridum hemihydricum...........................................................7–5704 Atropa belladonna ad praeparationes homoeopathicas ..............................................6–5284 Apis mellifera ad praeparationes homoeopathicas...................4–4711 Ammonii chloridum ................................................................................ 1165 Belladonnae pulvis normatus...................... 1160 Atracurii besilas..........................2–3984 Barii sulfas ........................................................................................................... 1525 Aluminii sulfas .................... 1615 Bacitracinum ................................................................ 8....................................................................................... 3221 Arginini aspartas.................. 8............ 1600 Atractylodis lanceae rhizoma...........................1–3710 Amoxicillinum natricum .... 1112 Aquae tritiatae (3H) solutio iniectabilis ...................................... 1180 Aurantii amari epicarpium et mesocarpium ..............................4–4712 Argenti nitras................................................. 8. 1111 Aqua purificata ................... 1148 Anisi fructus........... 1626 Beclometasoni dipropionas monohydricus .............................................................................. 1560 Ampicillinum anhydricum........ 1550 Amobarbitalum .. 8............. 1598 Atovaquonum..................................................................................................................................................................................................Index Aluminii phosphas hydricus................................................................. 8........... 1607 Azathioprinum ......................... 1158 Atenololum ............. ...............................4–4719 Carbimazolum........................................................................... 8................................................. 8......................................................................................... 1762 Carbidopum. 1670 Biotinum ................................................................................... 1646 Benzylpenicillinum benzathinum .................................................................. 1697 Bufexamacum............................................ 1696 Budesonidum .................. 1667 Bicalutamidum...................................... 1175 Bleomycini sulfas.....................................................................5–4972 Betahistini dihydrochloridum .......................................................... 1693 Bromperidolum ....... 8.....................................................................................................................................................................................................................................................4–4721 Carmellosum.................................................................. 1659 Betamethasoni dipropionas.................................................. 8....................................1–3728 Carbo activatus ....................................... 1706 Buprenorphinum............................ 1742 Calcii hydroxidum .............................. 1695 Brotizolamum...........................................................................................................6–5235 Carbonei dioxidum ..7–5711 Betamethasoni acetas................................................. 1796 Cefiximum .......................... 1781 Carvi aetheroleum ............................................................................................................. 1745 Calcii pantothenas ............................................................................................... 1717 Cadmii sulfas hydricus ad praeparationes homoeopathicas ................................................................... 1714 Butylis parahydroxybenzoas ................................................................. 8.. 1663 Betamethasoni valeras ........................................ 1760 Carbamazepinum................... 1668 Bifonazolum. 1768 Carbonei monoxidum.......... 1770 Carboprostum trometamolum ..................................................................................................................................................................................................................................................................................................................................................................................... 1753 Candesartanum cilexetili .............................................................. 1793 Cefazolinum natricum.............7–5829 Carboxymethylamylum natricum B..... 1728 Calendulae flos .4–4722 Carteololi hydrochloridum.................................. 1173 Bezafibratum ................................................... 1743 Calcii lactas monohydricus ......................... 1216 Caryophylli flos............................. 8...................2–3985 Calcii lactas anhydricus........................................................................................ 1750 Calcii sulfas dihydricus...................2–4007 Bromazepamum ................................... 1666 Betulae folium ....................... 1713 Butylhydroxytoluenum ..................................................................... 1048 Carboplatinum ...... 1745 Calcii laevulinas dihydricus ............................................... 1731 Calcii carbonas ......................... 1194 Capsici oleoresina raffinata et normata.............. 779 Captoprilum ........................................ 1729 Calcii ascorbas ............................................... 1771 Carboxymethylamylum natricum A ........................................................................................................ 8....................................................... 1653 Betadexum ......................................................................................... 1650 Betacarotenum ............7–5829 Carboxymethylamylum natricum C .................................................................................................................... 1799 5889 .......................... 1785 Cefadroxilum monohydricum........................ 8..............................7–5759 Cabergolinum ..............................................................................................................................2–3968 Carthami oleum raffinatum...................... 1648 Benzylpenicillinum natricum....................... 1740 Calcii hydrogenophosphas dihydricus ................ 8.................... 1751 Calcipotriolum anhydricum.............. 1215 Cefaclorum............... 1839 Carbocisteinum .................................................................................................................................... 3193 Carvedilolum ...... 1193 Camphora racemica................................................. 1711 Butylhydroxyanisolum.......................... 1647 Benzylpenicillinum kalicum..................... 1744 Calcii lactas trihydricus.....................2–3985 Calcifediolum.................................................................................................................. 1643 Benzylis benzoas....................................................... 8.................................... 1792 Cefatrizinum propylen glycolum ............................................ 8........................................................................................................................................................................... 1758 Carbacholum ........................................7–5687 Boldi folium ............... 1773 Carmellosum calcicum . 1681 Borax .................................................................................................................................................. 1722 Calcipotriolum monohydricum .......................................................... 8..........7–5712 Bromperidoli decanoas ....................................................... 1766 Carbomera .................... 1749 Calcii stearas............................ 1677 Bisoprololi fumaras ............................3–4412 Carisoprodolum.................................................................................... 1788 Cefalotinum natricum ......................................... 1776 Carprofenum ad usum veterinarium........... 8......................................................................................... 8................ 1673 Bismuthi subcarbonas............5–4973 Buflomedili hydrochloridum .......EUROPEAN PHARMACOPOEIA 8............... 1738 Calcii glycerophosphas ........................................................................................ 1743 Calcii iodidum tetrahydricum ad praeparationes homoeopathicas ................................................... 1661 Betamethasoni natrii phosphas........................................ 1724 Calcitoninum salmonis... 1705 Buserelinum ............................................................................. 1748 Calcii levofolinas pentahydricus .......................... 1744 Calcii lactas pentahydricus ..................................................................................... 1739 General Notices (1) apply to all monographs and other texts Index Calcii gluconas anhydricus..... 1780 Carthami flos .............................. 1676 Bismuthi subnitras ponderosus ....................... 1198 Capsulae............. 1737 Calcii gluconas ad iniectabile......................................... 1778 Carrageenanum.............................................................7 Benzoylis peroxidum cum aqua...................................................1–3727 Capsici extractum spissum normatum............... 1761 Carbasalatum calcicum ................................... 1657 Betaxololi hydrochloridum............................................ 1769 Carbonei monoxidum (15O) ........ 1733 Calcii dobesilas monohydricus...................... 8.. 1675 Bismuthi subgallas ..................... 1703 Buprenorphini hydrochloridum.................................................................... 1733 Calcii folinas ........................................... 1791 Cefapirinum natricum.................... 1692 Brompheniramini maleas ................. 1196 Capsici tinctura normata ..............4–4715 Bupivacaini hydrochloridum .... 8....................................... 1740 Calcii hydrogenophosphas anhydricus ...............................................................................6–5230 Buspironi hydrochloridum .......................................................... 8................................ 1197 Capsici fructus ............................................................................................................ 1655 Betahistini mesilas...................... 8................................................................................................................................................................................................ 1664 Betamethasonum.......................................................... 1199 Caryophylli floris aetheroleum............................... 1672 Bisacodylum...................................................................... 1731 Calcii chloridum dihydricum.................... 1786 Cefalexinum monohydricum ........................................ 1678 Bistortae rhizoma .... 1200 Carvi fructus............................................. 1775 Carmustinum ............................................................ 8......................................................................... 1774 Carmellosum natricum......... 8..............6–5229 Bromocriptini mesilas .................................... 1789 Cefamandoli nafas ...............1–3729 Cefepimi dihydrochloridum monohydricum .................................................................................................................. 1726 Calcitriolum...... 1682 Brimonidini tartras............................................................................................. 1754 Capecitabinum .................................. 8............... 1651 Benzylpenicillinum procainum . 1709 Busulfanum.................... 1969 Carmellosum natricum substitutum humile ......... 1687 Bromhexini hydrochloridum..........................................................................................................................................3–4280 Carmellosum natricum conexum ..... 1671 Biperideni hydrochloridum ................. 1676 Bismuthi subsalicylas ........................................7–5685 Boraginis officinalis oleum raffinatum ..................................................... 1720 Calcii acetas anhydricus ........................................................................ 8........................................ 1680 Boldi folii extractum siccum........................................................................................................................ 8............................................................. 1732 Calcii chloridum hexahydricum ...................................................................................................................................................................................................................................................................................................................................................................... 1734 Calcii glucoheptonas ....................................................... 8.................................... 1712 C C1-esterasi inhibitor humanus................................................................................................ 1700 Bumetanidum..................................................................................................... 1736 Calcii gluconas.............................................................................................................................................................. 8....................................... .............................................. 8.......................7–5718 Cisplatinum ......................................... 1823 Cellulosi acetas phthalas....................... 1911 Clindamycini hydrochloridum............................................................................ 1203 Cinnamomi cortex .................................................................................... 8............... 1836 Cetylis palmitas .......................................................... 1845 Chloramphenicolum ........................ 8......................................................................................................................................................... 1857 Chlorphenamini maleas .. 1849 Chlordiazepoxidum............................... 1863 Chlortetracyclini hydrochloridum ...........................................................4–4723 Cetrimidum ..................... 8........... 8..........................................................................................................................................2–4011 Chlorobutanolum anhydricum .................................... 8.................................................................................................................................. 1204 Centellae asiaticae herba ...........................................................................1–3702 Cinchocaini hydrochloridum ..................... 1916 Clobetasoni butyras...... 2419 Cellulosi acetas ..................................................................... 1960 Colistini sulfas ... 1807 Cefradinum................................. 1922 Clomipramini hydrochloridum............................................................................... 1049 Chymotrypsinum.... 1928 Closantelum natricum dihydricum ad usum veterinarium ............................................ 1874 Chondroitini natrii sulfas................. 1881 Ciclopiroxum ..........................................6–5367 Chinini hydrochloridum. 1838 Chamomillae romanae flos ...6–5239 Cimetidinum................................................................................................................... 1843 Chloramphenicoli natrii succinas..... 8....... 8...........................................4–4723 Chlormadinoni acetas.................. 1872 Cholesterolum.............................................................................................................4–4727 Ciprofloxacinum...........................1–3738 Clematidis armandii caulis ................................................... 1914 Clobazamum ................................................ 1824 Cellulosum microcristallinum et carmellosum natricum...... 1933 Clozapinum .......... 8.........................................................................................4–4725 Cisatracurii besilas ........... 1800 Cefotaximum natricum ...............................................................................................................................................................................................................................2–4012 Cholesterolum ad usum parenteralem .................. 1805 Cefprozilum monohydricum ........................................................... 8......................................................................................... 8.......................... 2566 Cetostearylis isononanoas ............ 1920 Clofibratum................... 1876 Chorda resorbilis sterilis ............................. 1217 Colae semen ....................................... 1117 Chorda resorbilis sterilis in fuso ad usum veterinarium ............ 8... 1926 Clopamidum ............... 1921 Clomifeni citras ............................................................................................................. 1210 Cinnamomi zeylanici folii aetheroleum.... 8...............7–5779 Centaurii herba ...........................................6–5237 5890 EUROPEAN PHARMACOPOEIA 8..................................7–5722 Clonazepamum ...................... 1870 Cholecalciferolum......................................... 1842 Chlorambucilum .. 1831 Cetobemidoni hydrochloridum ........ 1820 Cellulae stirpes haematopoieticae humanae ................................................................... 1899 Citaloprami hydrochloridum .......... 1811 Ceftazidimum pentahydricum et natrii carbonas ad iniectabile........................................................................................... 8............................................ 1818 Celecoxibum.................................. 1209 Cinnamomi zeylanici corticis aetheroleum ...........3–4284 Chlorhexidini digluconatis solutio........................................................ 1838 Cetylpyridinii chloridum ........................................................................................................................... 1883 Cilastatinum natricum .......................... 1865 Cholecalciferoli pulvis ..............................................7–5692 Citronellae aetheroleum .. 1801 Cefoxitinum natricum .................................................. 1857 Chloroquini sulfas ...................... 1941 Codeini phosphas sesquihydricus.................................................................................................................................................. 1308 Citri reticulatae epicarpium et mesocarpium............................................................. 1212 Cladribinum ........................................................................................................... 8........................ 1867 Cholecalciferolum densatum oleosum....................................... 1718 Coffeinum monohydricum ............................................. 8........................................................................................................................................ 1856 Chloroquini phosphas .................................................................... 1942 Codeinum... 8.................................................................................. 1939 Codeini phosphas hemihydricus ............................................................................. 1959 Colistimethatum natricum ............7 Ciclesonidum ... 8........................................................ 8...... 8................................. 8.......................................................................... 1719 Coicis semen...... 8..............................................Index Cefoperazonum natricum.......................................................................... 8......................... 1890 Cinchonae cortex............................... 1846 Chloramphenicoli palmitas ............................................................................................. 1809 Ceftazidimum pentahydricum ..............................................................6–5370 Chitosani hydrochloridum ........................................... 1885 Cimetidini hydrochloridum..................................................................................................................... 1908 Clemastini fumaras................................ 1803 Cefpodoximum proxetili.................................3–4283 Cellulosi pulvis............. 1630 Cetirizini dihydrochloridum ......................................................................4–4730 Colophonium ......................... 1855 Chlorocresolum................................................................ 8.......................................................................................................................... 1906 Clebopridi malas .............................................................................. 1218 Colchicinum................................................................................ 1900 Citri reticulatae aetheroleum .......................................................................... 1869 Cholecalciferolum in aqua dispergibile ............................................................ 8........................................................................ 1927 Clopidogreli hydrogenosulfas ............................... 1880 Ciclosporinum .............................................................. 1891 Cinnamomi cassiae aetheroleum ................................................................. 1206 Chelidonii herba................ 1630 Cera carnauba ............. 1817 Cefuroximum natricum...........3–4290 Clioquinolum..... 1957 Colestyraminum ............................................................................ 1934 Cocaini hydrochloridum................ 1904 Clazurilum ad usum veterinarium .....................................3–4288 Chlortalidonum............................. 1930 Clotrimazolum .......... 1892 Ciprofibratum........................................ 1828 Cellulosum microcristallinum....................................... 8............................................................................................................................ 8..................................................................................................7–5717 Celiprololi hydrochloridum .......... 1858 Chlorpromazini hydrochloridum ............ 1207 Cinchonae extractum fluidum normatum...................................................... 1844 Chlorcyclizini hydrochloridum ....................................................................................................... 1938 Codergocrini mesilas ......... 1214 Clenbuteroli hydrochloridum.......................................................................... 1903 Clarithromycinum .................................................................................................................................................................................. 8................................. 1841 Chlorali hydras ............................ 1848 Chlorhexidini diacetas .............................. 1211 Cinnarizinum ............................................ 1219 Compressi .......................................................................4–4730 Codeini hydrochloridum dihydricum............. 1815 Cefuroximum axetili ................................................. 809 See the information section on general monographs (cover pages) ........... 1268 Chinidini sulfas ...............................................6–5236 Cera flava ...................... 1127 Chromii (51Cr) edetatis solutio iniectabilis ....................6–5184 Cera alba .................................................... 1944 Coffeinum .......................................................................... 1859 Chlorpropamidum .............................................................................. 1912 Clindamycini phosphas ................................6–5238 Cimicifugae rhizoma............................................................................... 8......................................................... 1855 Chlorobutanolum hemihydricum............... 1861 Chlorprothixeni hydrochloridum .............................................................. 1925 Clonidini hydrochloridum...................................4–4728 Clofaziminum..................................................................................................................... 1915 Clobetasoli propionas..........................................................................3–4286 Chlorhexidini dihydrochloridum..6–5368 Chinini sulfas............................................. 1208 Cineolum............................................................................................................... 8...........................................................2–4013 Cilazaprilum.......... 1897 Citaloprami hydrobromidum................ 8..........3–4292 Cocoylis caprylocapras .................................. 1879 Ciclopirox olaminum ...............................................1–3731 Cellulosi acetas butyras............................ 1931 Cloxacillinum natricum ... 8................................. 1935 Cocois oleum raffinatum .................... 1893 Ciprofloxacini hydrochloridum ........................................................................................................... 1813 Ceftriaxonum natricum............................................... 1847 Chlordiazepoxidi hydrochloridum ...................... ...................... 2040 Dienogestum ................... 1051 Cyanocobalaminum............................................................................................................................................................................................................... 8............................... 2074 Dipivefrini hydrochloridum .............................................................................................................. 1987 Dalteparinum natricum ....................... 2018 General Notices (1) apply to all monographs and other texts Index Dexpanthenolum............................ 1050 Cyanocobalamini (58Co) capsulae ..................6–5248 Dihydrocodeini hydrogenotartras... 1974 Cyclopentolati hydrochloridum ...................................2–3988 Cupri sulfas anhydricus........................................................... 2068 Dinatrii clodronas tetrahydricus .................. 1980 Cystinum ................................................................................................... 2028 Diazepamum ................................................................................................ 765 Cortisoni acetas ............................................................................................... 2024 Dextromethorphani hydrobromidum .....6–5208 Dembrexini hydrochloridum monohydricum ad usum veterinarium ..........................................................1–3743 Dexamethasonum .....................4–4735 Dapsonum........................................................................................................................................ 1995 Demeclocyclini hydrochloridum ............ 2052 Dihydroergocristini mesilas................. 8..................... 2046 Digitalis purpureae folium .......................................................................................... 1227 Digitoxinum.......... 2058 Dihydrostreptomycini sulfas ad usum veterinarium ................................................... 2063 Dimercaprolum ...........................................................................................................................3–4297 Diphenhydramini hydrochloridum ................................... 8................3–4259 Curcumae zanthorrhizae rhizoma ....... 1977 Cyproteroni acetas ............................................................................................................ 2077 Dikalii phosphas............................. 2025 Dextromoramidi tartras ......................................... 2078 Diltiazemi hydrochloridum......2–3987 Crospovidonum ..... 8.......... 1965 Crataegi folii cum flore extractum fluidum quantificatum.................................................2–4016 Cyclizini hydrochloridum....... 2067 Dimetindeni maleas ............ 1962 Coriandri aetheroleum ...... 8............................3–4279 Decylis oleas ...................... 1998 Dequalinii chloridum...7–5727 Dibutylis phthalas ................................... 8................................................................... 8........... 1999 Desfluranum ............................................................................................................. 2084 Dinitrogenii oxidum ....................2–3963 Corpora ad usum pharmaceuticum .......................................................... 2014 Dexamethasoni natrii phosphas ................... 1269 Cyanocobalamini (57Co) capsulae ............................................................................... 2660 Copolymerum methacrylatis butylati basicum.................. 2075 Diprophyllinum ................................................................................................................................................................... 2078 Dipyridamolum..........................................................2–3963 Coriandri fructus.............................. 8............................................. 2003 Deslanosidum ...................................................... 2006 Desogestrelum...7–5699 Curcumae longae rhizoma ................................... 1978 Cysteini hydrochloridum monohydricum...........EUROPEAN PHARMACOPOEIA 8.................................................................... 8....................................... 2069 Dioscoreae oppositifoliae rhizoma....... 2085 Disulfiramum ........... 2030 Diazoxidum ...............2–4020 Dicloxacillinum natricum ........................ 2020 Dextranum 40 ad iniectabile...... 2079 Dirithromycinum ................................................................................................................................. 2039 Didanosinum .......... 2043 Diethylenglycoli palmitostearas ... 2048 Digoxinum ..............3–4258 Cyamopsidis seminis pulvis......................................... 8................................. 8...... 2082 Dinatrii etidronas......................5–4943 Cyproheptadini hydrochloridum ................ 8................... 8.......................................................................................................... 2865 Dinoprostonum ................................................................ 2089 5891 ............................................ 1975 Cyclophosphamidum ...................... 2023 Dextrinum......................... 2070 Dinoprostum trometamolum ......................... 2066 Dimethylis sulfoxidum.................................... 1271 Cresolum crudum......................................................... 8................................... 1273 Crataegi folium cum flore................................................................................................................... 2066 Dimeticonum ......................................... 2019 Dextranomerum ............................................................................ 2087 Dithranolum .......................................................................................................................................................................................................................................... 2008 Detomidini hydrochloridum ad usum veterinarium............................................................................................... 2022 Dextranum 70 ad iniectabile........ 1994 Deferoxamini mesilas .............................................................................. 1976 Cynarae folii extractum siccum ........................... 8................................................................................... 2031 Dibrompropamidini diisetionas...............................................................6–5247 Deptropini citras........................................................................ 1992 Daunorubicini hydrochloridum.................................................................................................... 8............ 1274 Crataegi folii cum flore extractum siccum .................... 1051 Cyanocobalamini (58Co) solutio ........................................................................................... 2734 DL-α-Tocopherylis hydrogenosuccinas .......................... 8.................................................... 2038 Dicycloverini hydrochloridum ...2–4019 Diclofenacum natricum............................ 8...................... 2041 Diethylstilbestrolum ........................... 1968 Croci sativi stigma ad praeparationes homoeopathicas . 8........... 2007 Desoxycortoni acetas............ 8...................................................................................................... 2026 Dextropropoxypheni hydrochloridum................ 2004 Desloratadinum.................................. 1981 Cytarabinum............................. 2005 Desmopressinum ............................ 2956 Dinatrii phosphas anhydricus..................................... 2086 Disopyramidum............... 1994 Delphinium staphisagria ad praeparationes homoeopathicas ................................................ 1988 Danaparoidum natricum .......................................................................................................................................................................6–5250 Diphenoxylati hydrochloridum............................................... 1272 Crataegi fructus ....... 1964 Cupri sulfas pentahydricus........................................................ 8............................................................................... 8........................................................ 8................................................................. 2061 Dikalii clorazepas .................................. 8.................................................6–5241 Crotamitonum....................................................................................... 8...................................................................................................................................6–5251 DL-Methioninum ......... 8.............................................. 2021 Dextranum 60 ad iniectabile..................... 1971 Cupri acetas monohydricus ad praeparationes homoeopathicas ................................................................................................................................ 8......................................... 3442 Dobutamini hydrochloridum.... 2084 Dinatrii phosphas dodecahydricus ................. 2002 Desipramini hydrochloridum.................... 1993 D-Camphora .............................................................................................................................7–5732 Dihydroergotamini tartras .. 1965 Cupri tetramibi tetrafluoroboras ad radiopharmaceutica................................................... 8.........................................................7 Copolymerum macrogolo et alcoholi poly(vinylico) constatum...... 2065 Dimethylacetamidum ............ 2083 Dinatrii phosphas dihydricus.......................4–4739 Dexamethasoni acetas ..................................................................................................................................................................................... 2044 Diethylis phthalas.........7–5728 Diethylcarbamazini citras ...........................................................................1–3705 Diosminum .................................................................................... 2045 Difloxacini hydrochloridum trihydricum ad usum veterinarium .... 2034 Diclofenacum kalicum ................ 2023 Dextranum 1 ad iniectabile ............................................................................................................................................... 2062 Dimenhydrinatum ........... 1982 D Dacarbazinum....................................... 1156 Cynarae folium...................................................................7–5729 Dihydroergotamini mesilas .............................................................................6–5173 Cuprum ad praeparationes homoeopathicas...................................... 2081 Disopyramidi phosphas ...........................................................................3–4306 Dinatrii pamidronas pentahydricus........................... 2059 Dihydrotachysterolum .................................................. 2042 Diethylenglycoli aether monoethylicus.. 8................................................................................................................................................... 2012 Dexamethasoni isonicotinas............... 2027 Diacereinum .............................. 1919 Dinatrii edetas .................................. 1624 Copovidonum ........... 2010 Dexchlorpheniramini maleas.......................................................................... 2033 Diclazurilum ad usum veterinarium ........ 1049 Cyanocobalamini (57Co) solutio .. 2049 Dihydralazini sulfas hydricus ...... ....................................... 2228 Ergotamini tartras...2–4022 Dydrogesteronum .................................. 8...2–4028 Filum bombycis tortum sterile in fuso ad usum Estradioli benzoas ......................... 1129 Estradioli valeras ...................... 1123 Eserini salicylas .............................................. 1345 Exemestanum ......................... 2180 Ethanolum (96 per centum) ................................................ 2146 Ferrosi gluconas....................... 2192 Ethylendiaminum.............. 8.........................................................................................................................5–4977 Ethanolum anhydricum .....................................4–4743 Drynariae rhizoma....... 2416 Emetini hydrochloridum pentahydricum .............. 2131 Factor XI coagulationis humanus....... 1239 Eucalypti folium ...................................... 1236 Fenbendazolum ad usum veterinarium.. 2193 Ethylis acetas.. 2188 Ethylcellulosum.......................................................................................................... 2113 Drospirenonum .................... 2151 Fila non resorbilia sterilia in fuso ad usum veterinarium .....................................................4–4750 Fila resorbilia synthetica monofilamenta sterilia..........................................................Index EUROPEAN PHARMACOPOEIA 8................ 2211 Enoxolonum...... 2097 Domperidonum ........................................................................................................................................................................................ 1122 Esketamini hydrochloridum...... 2095 Dopamini hydrochloridum ......................................................................................... 2418 Erythromycini stearas .............................1–3749 Famotidinum .......................................................................................................................................................................................................................................................................................................... 8...................................................................................... 2179 Ethambutoli hydrochloridum ............................................................................................... 2139 Felodipinum................................................................. 2134 Fagopyri herba.................................................7–5736 Doxylamini hydrogenosuccinas . 8...................................................... 2092 Dodecylis gallas .....................................................................................7–5742 Filum ethyleni polyterephthalici sterile in fuso ad usum Estradiolum hemihydricum .................................................................................. 2143 Fenofibratum ...................... 2105 Doxepini hydrochloridum ...................................... 2137 Felbinacum .................................................................. 2171 veterinarium ............ 2125 Eucommiae cortex...........2–4027 Filipendulae ulmariae herba...... 2101 Dosulepini hydrochloridum ................. 8.......5–4979 Ethinylestradiolum ........................ 2133 Factor VIII coagulationis humanus (ADNr) ........... 2103 Doxaprami hydrochloridum ............................................................................................................................................................................................................................ 2166 Filgrastimi solutio concentrata..............2–3965 E Ebastinum .............. 2190 Ethylis oleas ........................................................................ 2126 concentrata ...................................................... 3027 Fila resorbilia synthetica torta sterilia ....................... 2201 Etoposidum ....................................................................................................... 2225 Equiseti herba ........................................................................................................ 2169 veterinarium ........................................................6–5257 Echinaceae purpureae herba ... 2205 Echinaceae pallidae radix.... 8......................................................... 8................................. 2129 Factoris VIIa coagulationis humani (ADNr) solutio Eleutherococci radix............................ 2140 Fenoteroli hydrobromidum ...................................6–5252 Doxazosini mesilas........................................ 2220 Ephedrinum hemihydricum .......... 2116 Dutasteridum..........................................................................................................................................................................2–4033 Eplerenonum.......................................................................................4–4749 Ferri chloridum hexahydricum.......................................................... 8........................................ 2144 Fentanylum........ 8........ 8......................... 8. 2158 Fibrinogenum humanum ...............................7 Estrogeni coniuncti........................ 2212 Enrofloxacinum ad usum veterinarium .....................................................................6–5261 Esomeprazolum magnesicum dihydricum .....................................................3–4313 Erythromycini ethylsuccinas ................................................................................................................................................................................. 8........ 2215 Ephedrae herba ...... 8.... 2142 Fenbufenum .................................................................................................................................................................... 2173 Filum lini sterile in fuso ad usum veterinarium ...................................................................................................3–4304 Ethosuximidum ... 1357 Echinaceae purpureae radix......................................................................................... 8......... 1229 Duloxetini hydrochloridum.....................3–4343 Emedastini difumaras....................... 2191 Ethylis parahydroxybenzoas natricus........................... 1129 Erythropoietini solutio concentrata ............................................................................................................................................................. 2218 Ephedrini racemici hydrochloridum ........................ 1316 Esomeprazolum magnesicum trihydricum .................................................... 2156 Fibrini glutinum ....................................................................... 2098 Dopexamini dihydrochloridum ............................................................................................... 2197 Etofenamatum ..... 8................. 2154 Fexofenadini hydrochloridum.............................................................. 8...... 8........................ 1237 Ferrosi fumaras .......... 1327 Eugenolum ............. 2174 Etamsylatum...........................7–5734 Doxycyclinum monohydricum..................................... 1129 Estriolum................................................ 2217 Ephedrini hydrochloridum ..........................................................2–3989 Erythromycini estolas.................................................................... 1240 Echinaceae angustifoliae radix..............................................7–5747 Epirubicini hydrochloridum.................................................................. 8................................................................................... 2435 Econazoli nitras................... 2108 Doxycyclini hyclas ...................................................................................................................................................................3–4314 Erythromycini lactobionas ................... 2130 Factor VII coagulationis humanus .................................... 2106 Doxorubicini hydrochloridum .................................7–5741 Felypressinum ............................................................................................................. 8............................ 2136 Febantelum ad usum veterinarium.......... 2214 Entecavirum monohydricum .............. 2219 Ephedrinum anhydricum ........................................................................................................................................ 8....................... 2213 Entacaponum.................................................. 2149 Ferrosi sulfas heptahydricus ................. 2150 Ferrum ad praeparationes homoeopathicas ............ 2227 Ergometrini maleas ...................... 2408 Emplastra transcutanea............................................................................................................................................... 1231 Factor humanus von Willebrandi.......... 8....................................................................................... 1128 Docetaxelum anhydricum ................................................................................6–5286 Edrophonii chloridum.................................... 3243 Ethylmorphini hydrochloridum .......................................................3–4306 Eucalypti aetheroleum ........................... 2127 Factoris IX coagulationis humani (ADNr) solutio Econazolum ................. 2141 Fentanyli citras .... 2178 Ethacridini lactas monohydricus ............................... 2094 Domperidoni maleas................................... 2190 Ethylis parahydroxybenzoas.............................................................................7–5760 Enilconazolum ad usum veterinarium ............. 798 Factor VIII coagulationis humanus...... 2414 Enalaprilatum dihydricum................................................................................ 8................................ 2229 Erythritolum ..... 2415 Enalaprili maleas ................................................................................. 2129 Factor IX coagulationis humanus........................................................................................................................................................... 2194 Etilefrini hydrochloridum.......................... 2148 Ferrosi sulfas desiccatus .......... 8.......................................... 1359 F Ecliptae herba . 8...................................... 2120 5892 See the information section on general monographs (cover pages) .............. 8............. 2196 Etodolacum .................................. 8.............. 2199 Etomidatum ............. 2226 Ergocalciferolum....... 2160 Fila non resorbilia sterilia .................... 2145 Fenticonazoli nitras .... 2099 Dorzolamidi hydrochloridum ......... 2193 Ethylenglycoli monopalmitostearas ............. 2090 Docetaxelum trihydricum ................................................................................................. 8................................................................................................................................... 2186 Ethionamidum............................................................................. 1234 concentrata ....... 2223 Epinastini hydrochloridum ............................................................................................................................................................................................................................ 1118 Erythromycinum ............................................................... 2112 Droperidolum ....................................... 1190 Enoxaparinum natricum.................................... ............. 8.....................2–3957 Fludrocortisoni acetas...................................................... 2245 Flucytosinum ............................................................................................................................................... 1225 General Notices (1) apply to all monographs and other texts 5893 ................................................................................... 2351 Glyceroli dibehenas ..................................................... 1222 Granisetroni hydrochloridum .............. 2339 Glucosum anhydricum ............ 1177 Foeniculi dulcis fructus......................... 2272 Flurbiprofenum ..........................6–5190 Gabapentinum................................................................................... 1968 Gramicidinum ........................................4–4759 Foscarnetum natricum hexahydricum........................................................6–5277 Glutathionum ................... 2325 Gentamicini sulfas.......... 2248 Fludeoxyglucosi (18F) solutio iniectabilis...........................................6–5273 Galantamini hydrobromidum ...................... 8.................................... 2354 Glyceroli monostearas 40-55 .................................................................................................................................... 1176 Foeniculi amari herbae aetheroleum ..............7 Filum polyamidicum-6/6 sterile in fuso ad usum veterinarium . 2275 Fluticasoni propionas........................................................ 2362 Goserelinum..........................................................3–4240 Fructosum ............................................................................................. 2300 Fosfomycinum trometamolum............. 1286 Fulvestrantum ....6–5275 Glucosum liquidum.............6–5267 Fucus vel Ascophyllum................................................................................................5–4984 Glycopyrronii bromidum..................................... 8................................................................................................................................ 8........... 1441 Granula homoeopathica velata.................... 2382 Halothanum..........6–5268 Fumariae herba ......................................................3–4327 Index Galactosum ................................................................................................. 2268 Fluphenazini dihydrochloridum........... 2266 Fluphenazini decanoas ................ 2299 Fosfomycinum natricum .. 8.................... 8................................................... 8............... 2243 Fluconazolum ...... 2346 Glycerolum (85 per centum) .....................................................................................................5–4935 Fluoromisonidazoli (18F) solutio iniectabilis............... 1060 Gallii (68Ga) edotreotidi solutio iniectabilis... 8................. 1259 Ginseng extractum siccum........... 2335 Glossa .................................................... 8..................... 8......................................................................................................... 1056 Fluoroethyl-L-tyrosini (18F) solutio iniectabilis................EUROPEAN PHARMACOPOEIA 8.............................6–5263 Fludarabini phosphas ................................................ 2338 Glucosamini sulfas kalii chloridum................................................................. 8..................................................................... 8......................................................................................................................... 2255 Flunitrazepamum......................................... 2278 Fluvastatinum natricum. 8............................ 1060 Gallii (68Ga) chloridi solutio ad radio-signandum... 2251 Flumequinum ......... 2349 Glyceroli distearas .........................3–4331 Gemcitabini hydrochloridum....... 1247 Frangulae corticis extractum siccum normatum ....................... 8.............................................................................................. 8..................................................................3–4316 Formaldehydi solutio (35 per centum)...6–5173 Ganciclovirum .... 2281 Foeniculi amari fructus ........................ 2305 Frangulae cortex............................................................................................................................................. 2235 Flavoxati hydrochloridum........................................................ 2256 Flunixini megluminum ad usum veterinarium .....7–5753 Glycerolum......... 1128 Finasteridum................................................................................................ 8..................................................................................... 2274 Flutamidum .................. 2361 Gonadotropinum sericum equinum ad usum veterinarium .................................................................... 2301 Fosinoprilum natricum................ 2366 Granula ad praeparationes homoeopathicas...... 1058 Fluorouracilum..........................................................................6–5278 Gossypii oleum hydrogenatum........... 2330 Gliclazidum........................................... 2302 Framycetini sulfas ....................... 1257 Ginkgonis folium ..................... 8...........1–3757 Flubendazolum....... 2383 Haloperidolum ................................................ 2262 Fluoridi (18F) solutio ad radio-signandum ........6–5265 Flutrimazolum........3–4321 Follitropinum............... 8.................. 8................................... 2297 Fosfomycinum calcicum ............................................ 2370 Guanethidini monosulfas ............... 1157 Fraxini rhynchophyllae cortex ......... 2353 Glyceroli mono-oleas............ 8............................................................... 2260 Fluoresceinum natricum.. 8............................................................................ 2350 Glyceroli monocaprylas .......................... 8....................................... 8.................................................................................................................. 2337 Glucosamini hydrochloridum ...................... 1270 Gadobutrolum monohydricum................................................................................................................................................ 2368 Guaifenesinum............................. 8..................... 1262 Ginseng radix................................................................................................................................................................................................. 2365 Graminis rhizoma .................. 2279 Fluvoxamini maleas................................................... 2341 Glucosum liquidum dispersione desiccatum............................................................. 2242 Flucloxacillinum natricum...................5–4983 Glycerol-formalum ................................................................................. 1054 Flumazenilum...................5–4948 Furosemidum............. 2352 Glyceroli monolinoleas ............................................................................................... 2319 Gallii (67Ga) citratis solutio iniectabilis........................................................ 1242 Follitropini solutio concentrata............................ 1241 Foeniculi amari fructus aetheroleum ................ 2381 Haloperidoli decanoas ............................................................................................................................................................................................................................................................................ 2254 Flunarizini dihydrochloridum ......................................... 8............................................. 2250 Flumazenili (N-[11C]methyl) solutio iniectabilis......................................... 2263 Fluoxetini hydrochloridum .................................... 8....................... 8.......... 2371 Guar galactomannanum ............ 1255 Gestodenum ................................................................. 2253 Flumetasoni pivalas .................................... 2360 Gonadotropinum chorionicum ...................... 1128 Filum polyamidicum-6 sterile in fuso ad usum veterinarium ................................. 2238 Flecainidi acetas .................. 2257 Fluocinoloni acetonidum.................................... 2332 Glimepiridum ....................... 2348 Glycinum. 2241 Flucloxacillinum magnesicum octahydricum................ 8......... 8....................................................................................................................................................................7–5757 G Hamamelidis cortex ....................4–4757 Fluocortoloni pivalas ............................................. 1441 Granula homoeopathica imbuta................. 2371 H Halofantrini hydrochloridum ........................................................................................... 2351 Glyceroli monocaprylocapras ........................................ 2321 Gefitinibum.. 2273 Fluspirilenum .........................................5–4947 Fraxini folium...................... 779 Glucagonum humanum....................................................................... 2264 Flupentixoli dihydrochloridum....................................................... 2317 Hamamelidis folium ...............3–4333 Glucosamini sulfas natrii chloridum.................................................................. 2271 Flurazepami monohydrochloridum ......... 2295 Formoteroli fumaras dihydricus ............................................................................................................................................................................................. 8................................................................................................................................................................................................................................................................................................................................................................ 8.............. 8................................................................... 2355 Glyceroli trinitratis solutio ...................................................... 2328 Ginkgonis extractum siccum raffinatum et quantificatum.....................3–4264 Granulata..........6–5188 Glibenclamidum...................................5–4949 Gentianae tinctura .............................7–5751 Harpagophyti extractum siccum................................................... 785 Griseofulvinum........................................................................ 1055 Fluorodopae (18F) ab electrophila substitutione solutio iniectabilis .......................................................6–5273 Glipizidum ............................................................................................. 2269 Fluphenazini enantas .................................................................... 8.... 2358 Gonadorelini acetas ..................................... 2326 Gentianae radix............ 2367 Guaiacolum .................... 2259 Fluoresceinum .......................7–5752 Gelatina............................................................................. 8...................................................................3–4332 Gemfibrozilum......................................................... 2342 Glucosum monohydricum ......................................................................................................... ............................................................................................................... 2493 Insulinum isophanum iniectabile ....... 2454 Hydroxypropylbetadexum..................... 8................... 2436 Hydralazini hydrochloridum ........................ 2394 Hexamidini diisetionas...................... 2476 Imatinibi mesilas .2–4050 Hydroxypropylcellulosum....................... 8. 2468 Hypromellosum ........................... 8............................ 1448 Helianthi annui oleum raffinatum..... 1065 Indii (111In) oxini solutio ..................................................... 2449 Hydroxocobalamini acetas..............3–4348 Immunoglobulinum humanum hepatitidis B ad usum intravenosum.............. 2494 Insulinum porcinum ............................................................... 8.................................................................................................. 8...................................2–4041 Homatropini hydrobromidum .................... 1450 Hyperici herba .............................. 8.................................................. 2452 Hydroxycarbamidum................................................................ 1030 Immunoserum tetanicum ad usum humanum........................................................................................................................................................................ 1068 Iobenguani (131I) solutio iniectabilis ad usum therapeuticum........................................................... 2465 Hyoscyamus niger ad praeparationes homoeopathicas ..................................................................................5-hydricus ..... 2505 Interferoni gamma-1b solutio concentrata ............................................................................................................................................... 8............................................................. 2402 Hyaluronidasum .......... 8. 8................................ 8........................................................................... 8.............. 1029 Immunoserum contra venena viperarum europaearum..................................................................................... 2494 Interferoni alfa-2 solutio concentrata ......... 2464 Hyoscinum ...... 2460 Hyoscini butylbromidum................................................................................................................... 2459 Hymecromonum.................................. 2511 Iodomethylnorcholesteroli (131I) solutio iniectabilis ..... 1266 Hydrochlorothiazidum ................7–5767 Imipenemum monohydricum ........................... 8.................................. 8..............................................3–4349 Immunoglobulinum humanum morbillicum ............................................................................................................................... 2451 Hydroxocobalamini sulfas...... 3354 Helium............ 8................................................................................................................................................... 8............................... 2480 Indii (111In) chloridi solutio .......... 8.......6–5291 I Ibuprofenum ................................................... 2520 Iotrolanum...... 2434 Immunosera ad usum veterinarium ............................................................................................................... 2396 Hexylresorcinolum ........2–4056 int-rac-α-Tocopherolum ....................... 8.. 8.4–4765 Hydrargyri dichloridum ...................................3–4341 Heptaminoli hydrochloridum ........ 2392 Heparinum calcicum .............................. 2446 Hydrocortisonum . 1280 See the information section on general monographs (cover pages) ................. 2518 Iopromidum...........................................................................................................................................6–5283 Hibisci sabdariffae flos...................... 8......... 750 Immunosera ex animale ad usum humanum ............... 2514 Iopamidolum ...................................................................................... 1066 Indii (111In) pentetatis solutio iniectabilis ..................................................... 748 Immunoserum botulinicum ...................................................................................................... 8..........................................................7–5689 Ipecacuanhae radix .. 2479 Immunoglobulinum anti-T lymphocytorum ex animale ad usum humanum........................ 2439 Hydrocodoni hydrogenotartras 2.................... 1066 Indinaviri sulfas .............................................................7–5758 Hexetidinum .............................. 1393 Hypericum perforatum ad praeparationes homoeopathicas ......................... 3436 int-rac-α-Tocopherylis acetas....3–4339 Heparinum natricum................... 1040 Indapamidum.......3–4343 Immunoglobulinum humanum anti-D ad usum intravenosum........... 8..................... 2453 Hydroxyethylcellulosum ........ 2450 Hydroxocobalamini chloridum........................ 1033 Immunoserum diphthericum ............3–4357 Immunoglobulinum humanum tetanicum.............................. 8........................................................ 8.................................................................................................................................... 2476 Iecoris aselli domestici oleum.......................................... 1449 Hydrastis rhizoma.................................................................................................................... 1226 Hederae folium ....... 2511 Iohexolum ..................... 1064 Iodixanolum ............................................ 2461 Hyoscyamini sulfas .................................................................................... 2528 Isatidis radix ... 3438 Iobenguani (123I) solutio iniectabilis ............ 8.... 8................................ 8..........Index Harpagophyti radix...................3–4365 Insulinum humanum....................................... 2523 Ipecacuanhae extractum fluidum normatum ................................................................................................................................6–5297 Insulinum glarginum ............................................................. 1391 Hyperici herbae extractum siccum quantificatum......................1–3707 Hedera helix ad praeparationes homoeopathicas ............................................................................. 1033 Immunoserum tetanicum ad usum veterinarium .. 2501 Insulinum aspartum ..............................................................................6–5299 Insulinum isophanum biphasicum iniectabile ................7–5690 Ipecacuanhae tinctura normata ................................................................. 1029 Immunoserum gangraenicum (Clostridium novyi) .......................................................... 2455 Hydroxyethylis salicylas............................... 8................................................... 8................................................................................ 8.............................................................................................. 1368 Histamini dihydrochloridum .................... 2448 Hydromorphoni hydrochloridum ............................ 800 Insulini zinci amorphi suspensio iniectabilis........................ 8. 2482 Indometacinum .........7–5761 Hydrocortisoni hydrogenosuccinas...................3–4351 Immunoglobulinum humanum rabicum........................................................... 2475 Idoxuridinum ................... 1451 Hypromellosi phthalas .....7–5700 Histidini hydrochloridum monohydricum.... 8...................... 2442 Hydrogenii peroxidum 30 per centum ............. 1946 Iecoris aselli oleum A ................................................................................................................. 2502 Insulini zinci suspensio iniectabilis................................................................................... 2485 Insulinum biphasicum iniectabile ........ 2502 Insulini zinci cristallini suspensio iniectabilis ........... 1070 Iodum ........................................................................ 2494 Insulinum lisprum................ 8..................................... 2527 Irbesartanum ............................................................7 Immunoglobulinum humanum hepatitidis B ......... 8............................................. 1032 Immunoserum gangraenicum mixtum ........................... 1067 Iobenguani (131I) solutio iniectabilis ad usum diagnosticum..............................................2–4055 Inhalanda.................................................. 2440 Hydrocortisoni acetas ................. 2478 Imipramini hydrochloridum .................................................................................. 1950 Iecoris aselli oleum B .......................................2–4042 Histidinum ............................. 1954 Ifosfamidum..............................5–4989 Interferoni beta-1a solutio concentrata.... 8....... 1575 Immunoglobulinum humanum anti-D .........................................3–4359 Immunoglobulinum humanum varicellae ad usum intravenosum.........6–5301 Insulinum solubile iniectabile .............................................................................. 2715 Hydrastis canadensis ad praeparationes homoeopathicas ............................3–4355 Immunoglobulinum humanum rubellae ...................... 8....................3–4359 Hydroxypropylcellulosum substitutum humile ..3–4348 5894 EUROPEAN PHARMACOPOEIA 8...................7–5691 Ipratropii bromidum.................................................................................... 8..... 2387 Heparina massae molecularis minoris..3–4349 Immunoglobulinum humanum normale ad usum intramusculum ...................7–5688 Ipecacuanhae pulvis normatus ............................................... 1069 Iobenguani sulfas ad radiopharmaceutica................... 2473 Ichthammolum ....................... 2423 Immunoglobulinum humanum normale ad usum subdermicum ................................................. 2407 Immunoglobulinum humanum hepatitidis A ...................... 1070 Iodinati (125I) humani albumini solutio iniectabilis ....................... 2462 Hyoscini hydrobromidum .......... 1030 Immunoserum gangraenicum (Clostridium perfringens) ................... 2398 Histaminum ad praeparationes homoeopathicas.......................................... 8................................. 2401 Homatropini methylbromidum .............7–5763 Hydroxyzini hydrochloridum ..........3–4349 Immunoglobulinum humanum normale ad usum intravenosum..................................................... 2448 Hydrogenii peroxidum 3 per centum ........................................................................3–4357 Immunoglobulinum humanum varicellae................................................................................................. 1031 Immunoserum gangraenicum (Clostridium septicum) .... 2493 Insulinum bovinum ............................... .... 8........... 8...................................................................................................................................................................................... 2646 Lynestrenolum ....... 2660 Macrogoli aether stearylicus. 2557 Josamycinum ............................................ 1296 Liquiritiae radix .................................................................. 2656 Macrogol 40 sorbitoli heptaoleas ...................................................................................................................................................................................................... 2555 Juniperi aetheroleum ...................................................................................................................... 1285 Juniperi galbulus ......................................... 8.................................................................................................................................................................................................................................................................................................. 8....... 2634 Loratadinum................................................................................... 2601 Levamisoli hydrochloridum ................ 2618 Lichen islandicus .................. 2548 Ivermectinum.......................................................................................6–5363 Kalii iodidum................................ 8................................................................................................................................. 3077 Kanamycini monosulfas ......................................................................................................................... 2547 Itraconazolum ............... 1295 Liothyroninum natricum ..... 2607 Levodopum ................................................................................................. 8.......................................................................................................... 2664 Macrogolglyceroli ricinoleas .......7 Isoconazoli nitras .................................................................................................................................................................................. 3216 Lactitolum monohydricum ............................................................................................................................................... 2536 Isoprenalini hydrochloridum ......................................................................... 3071 Kalii hydrogenotartras............................................................................................ 2615 Levothyroxinum natricum ................................. 2545 Isradipinum ........ 1967 Lauromacrogolum 400 ................ 2577 Lacca........................................................... 1274 Lycii fructus ...................... 8.................................................... 2610 Levomentholum............................................................... 8...................................................5–4999 Macrogoli aether laurilicus ..................................... 2540 Isosorbidi mononitras dilutus ........................6–5316 Lactulosum ..... 2630 Loperamidi hydrochloridum .. 2898 Macrogolglyceridorum stearates ....................... 3068 Kalii dihydrogenophosphas ............................................................... 2622 Lini oleum virginale..........................................................4–4775 Levetiracetamum.................. 3075 Kalii permanganas ............... 3065 Kalii citras.................................4–4802 Kalii carbonas.......... 8............... 1301 Levocabastini hydrochloridum... 2604 Levistici radix ................................... 2564 Kanamycini sulfas acidus ............................................................................. 1073 Lobelini hydrochloridum ................................... 8................................................................................................................................................................................................. 1292 Lincomycini hydrochloridum........................................................................... 2665 Macrogola massae molecularis magnae.......................................................................... 2611 Levomepromazini hydrochloridum .............................. 8.............................. 2655 Macrogola ............................................................................................................................................... 3065 Kalii clavulanas ............ 2638 Lorazepamum.................................. 3074 Kalii perchloras....................................................................... 2665 Macrogoli 15 hydroxystearas .............................................................. 2598 Leucinum ........................................................................................................................ 2629 Lomustinum.......2–4065 Lini semen ........................... 2657 Macrogoli aether cetostearylicus ................................................................. 2613 Levomethadoni hydrochloridum ................... 3072 Kalii hydroxidum ......................................................... 2614 Levonorgestrelum ...................................... 2624 Macrogolglyceridorum oleates...................5–4995 Lupuli flos .. 3076 Kalii sulfas................................................................................................................................................................................................................................................................................................................ 1291 Lavandulae flos......... 2621 Lidocainum ....................................... 2571 Ketotifeni hydrogenofumaras.................................................................................................. 2625 Liquiritiae extractum siccum ad saporandum .........................................3–4375 Macrogolglyceridorum caprylocaprates.............................................................. 8................................................................ 2563 Kaolinum ponderosum .................. 2612 Levomepromazini maleas.... 2580 Lactosum anhydricum.... 3064 Kalii chloridum ....................................................................................................................................................................... 2530 Isofluranum ........................ 2543 Isoxsuprini hydrochloridum........................................................................................................................................................................................................................................... 2565 Ketamini hydrochloridum...................................................................... 2649 Lysini hydrochloridum........................................... 2587 Lamivudinum ..................................................... 2657 Macrogol 6 glyceroli caprylocapras..... 1757 Macrogolglyceridorum laurates ................................................... 1289 General Notices (1) apply to all monographs and other texts Index Leflunomidum ..................................................................6–5308 Isomaltum .......... 8............................ 3070 Kalii hydrogenoaspartas hemihydricus................................ 2542 Isotretinoinum ...................... 8................................................................ 2663 Macrogolglyceroli hydroxystearas.......... 3070 Kalii hydrogenocarbonas ...... 2537 Isopropylis myristas.......3–4371 Lactulosum liquidum........................................................ 2594 Lavandulae aetheroleum .................................... 2628 Lithii citras....................... 1285 K Kalii acetas.... 1324 Letrozolum . 1071 L Labetaloli hydrochloridum........... 2531 Isoconazolum.......................... 8................................ 2631 Loperamidi oxidum monohydricum .........................................4–4777 Lithii carbonas.................. 2628 L-Methionini ([11C]methyl) solutio iniectabilis .................................................................................................. 8.....................6–5310 Isoniazidum ...................................................................................................................................................................................................................................................................................................................... 2620 Limonis aetheroleum ................................ 2641 Lovastatinum ... 2540 Isosorbidi dinitras dilutus....................................................... 2658 Macrogoli aether oleicus .................. 2658 Macrogoli aether isotridecylicus ................................ 2532 Isoleucinum....................6–5319 Lythri herba .............1–3783 Kryptonum (81mKr) ad inhalationem .................................. 8..........1–3787 Lansoprazolum ................. 2608 Levodropropizinum.......7–5769 J Josamycini propionas........................ 2643 Lufenuronum anhydricum ad usum veterinarium ............ 3314 Macrogolglyceroli cocoates ....4–4776 Levamisolum ad usum veterinarium ...................... 8....................................6–5317 Leuprorelinum ............................... 2648 Lysini acetas..................................................................................................................................... 3066 Kalii clavulanas dilutus ............................................................................... 2662 5895 ...................... 3063 Kalii bichromas ad praeparationes homoeopathicas ........... 2569 Ketorolacum trometamolum..................................... 2592 Lanugo cellulosi absorbens ......EUROPEAN PHARMACOPOEIA 8............... 8....................................................................................2–3990 Kalii bromidum ................................................................... 2639 Losartanum kalicum.......... 8.......................6–5315 Lactosum monohydricum......... 2539 Isopropylis palmitas .................... 2589 Lamotriginum ..................................................................................................................................... 3075 Kalii sorbas ..................................... 2596 Macrogolglyceridorum linoleates ................................................................................................ 2633 Lopinavirum ........ 8........... 1275 Lidocaini hydrochloridum............................................................................................................................................................4–4705 Lymecyclinum..................................................................................... 2567 Ketoprofenum .......................................... 1298 Lisinoprilum dihydricum. 1300 M Macrogol 20 glyceroli monostearas...... 3073 Kalii metabisulfis................................ 8................................... 2597 Leonuri cardiacae herba...................... 3073 Kalii natrii tartras tetrahydricus ............................... 3542 Lanugo gossypii absorbens................................................................................................................................ 2565 Ketoconazolum ................................2–4063 Levocarnitinum ..................... 2655 Macrogoli 30 dipolyhydroxystearas ............................................ 3076 Kalii nitras .................. 2536 Isoprenalini sulfas ................................................................................................ ................. 2671 Magnesii chloridum hexahydricum.......................................................................................................................................................... 2717 Mesnum............................................. 8............................................................ 2747 Methylprednisoloni acetas.......................................................................6–5324 Methyldopum ..................................................................................................... 2673 Magnesii citras nonahydricus ............ 2810 Myristicae fragrantis aetheroleum........................................ 2691 Mangani sulfas monohydricus ................ 8................................ 2659 Macrogoli stearas.................................................................................. 3255 Methylis salicylas............. 2744 Methylhydroxyethylcellulosum ................................................................................................................................. 2766 Metronidazoli benzoas....................... 2691 Mannitolum.................................. 1323 Menthae piperitae aetheroleum .............................................................................................................................................. 2708 Menadionum ....................... 2689 Malvae folium......................................................................................................................... 2670 Magnesii sulfas heptahydricus ........................................................ 8...................................................................................................... 8...... 2673 Magnesii citras dodecahydricus ...................................................... 2699 Mefloquini hydrochloridum ............ 2710 Menthae arvensis aetheroleum partim mentholum depletum......................4–4785 Metrifonatum ............................................................................6–5329 Metixeni hydrochloridum............................................ 2783 Mitomycinum ...................................... 2688 Maltodextrinum ........................................2–3976 Minocyclini hydrochloridum dihydricum...................................................................................................................... 8............................... 8.............................. 2731 Methanolum .............................................. 8.......... 8......2–4070 Magnesii glycerophosphas................................................................ 8.............. 2732 Methanum ........................................................................................................................ 2683 Mebendazolum .............................................................................................................. 8..... 2684 Maydis oleum raffinatum......... 2762 Metoprololi succinas ....7 Meropenemum trihydricum.......................................... 2746 Methylphenobarbitalum .................................................. 2741 Methyleni chloridum............ 2711 Menyanthidis trifoliatae folium............................................................................................................................................................................................................... 2714 Mercaptopurinum ................................. 8....................................................................................................................................................................................................... 1306 Malvae sylvestris flos..........................................................7–5775 Mesalazinum ......2–3991 Magnesii hydroxidum ............................................................................ 2712 Meprobamatum................................................................................2–4071 Mangani glycerophosphas hydricus........................................... 8...............................................................................................5–4999 Melphalanum ....................................................................................................................................... 2796 Morphini hydrochloridum ......................... 8......... 8..................................................... 8.... 8...... 2797 Morphini sulfas ...............................4–4781 Marrubii herba .............................................................2–4072 Maprotilini hydrochloridum ...............................................................................................................................3–4375 Magnesii lactas dihydricus .......................................... 1319 Melissae folium..................... 8.......................................................................................... 1318 Meloxicamum................ 2677 Magnesii peroxidum.............. 1352 Menthae piperitae folium ........................................................... 2720 Mesterolonum...................... 1353 Menthae piperitae folii extractum siccum ......... 8............................................... 8........................................ 8......3–4384 Mianserini hydrochloridum ......................... 2739 Methylphenidati hydrochloridum.......... 8....................................................................................6–5323 Methotrexatum........................................................ 1317 Melissae folii extractum siccum ..5–5001 Miconazoli nitras ..... 2733 Methioninum......................Index Macrogoli oleas............................................................................................... 2805 Mupirocinum calcicum....................................... 1334 Myrrha ...........................................................................7–5776 Methylrosanilinii chloridum ...................... 2677 Magnesii oxidum ponderosum................. 2787 Molgramostimi solutio concentrata.............................................................. 2702 Megestroli acetas .............................. 2786 Modafinilum..... 2671 Magnesii subcarbonas ponderosus........................................... 2687 Maltitolum liquidum ......... 2669 Magnesii chloridum 4.....................................................................3–4378 Meliloti herba .............................. 1314 Matricariae extractum fluidum ............................ 2696 Meclozini dihydrochloridum........... 8.................... 2668 Magnesii aspartas dihydricus................................1–3791 Metformini hydrochloridum .................................................... 1327 Myrtilli fructus recens..................... 1311 Matricariae aetheroleum ...........2–4069 Magaldratum ........................................................................... 2713 Mepyramini maleas ........7–5780 Millefolii herba .............................................. 2803 Moxonidinum........................................................................... 2791 Mometasoni furoas ........................................................... 2704 Megluminum ......................4–4784 Metoprololi tartras ............. 8...............................................................................7–5693 Maydis amylum.... 2679 Magnesii stearas ....... 2694 Marbofloxacinum ad usum veterinarium .... 2808 myo-Inositolum ................... 2683 Magnoliae officinalis cortex ........................................................................................................... 784 Mycophenolas mofetil ........ 2676 Magnesii oxidum leve .................. 8...................... 2723 Metamizolum natricum monohydricum ...................................... 1401 Meldonium dihydricum....................................................................................................... 2788 Molsidominum .................................................................................................. 1187 Mepivacaini hydrochloridum......................... 2761 Metoclopramidum.......................... 2674 Magnesii gluconas ... 2780 Mirtazapinum .................... 8.......................................................... 2682 Magnesii trisilicas.1–3709 Magnoliae officinalis flos ............................ 2715 5896 EUROPEAN PHARMACOPOEIA 8.. 8................................................................................................................ 2685 Maltitolum .................................................3–4379 Methenaminum............................4–4782 Methadoni hydrochloridum ................................... 2738 Methylis parahydroxybenzoas natricus........................................................................................... 2769 Metronidazolum.. 2799 Moxidectinum ad usum veterinarium ....................... 2678 Magnesii pidolas..................... 8................... 1326 Myrrhae tinctura....................................6–5184 See the information section on general monographs (cover pages) ..................... 2781 Misoprostolum........................... 2792 Montelukastum natricum .......................... 8.............. 2672 Magnesii citras anhydricus................................................... 8..... 1305 Mangani gluconas ..................................................................................................................................................................................7–5778 Methylthioninii chloridum ................. 8................................................................ 8................................. 2721 Mestranolum...........................................6–5328 Methylprednisolonum.......... 2403 Melaleucae aetheroleum ......................................................................... 781 Mastix............... 1350 Mentholum racemicum ....................................................................................................................................................................................................................................................... 2722 Metacresolum .................................... 2706 Mel ....................5–5002 Midazolamum ... 1313 Matricariae flos ....................................................... 8.................................................................................................6–5331 Miconazolum .................... 2675 Magnesii hydrogenophosphas trihydricus ad praeparationes homoeopathicas ............................. 2800 Moxifloxacini hydrochloridum ........................................... 2759 Metoclopramidi hydrochloridum................ 8..... 8...................................... 2807 Musci medicati .....................................................................7–5782 Mitoxantroni hydrochloridum.................................... 2804 Mupirocinum................................................................... 2755 Methyltestosteronum....6–5326 Methylprednisoloni hydrogenosuccinas ............................................................ 2760 Metolazonum................................... 2768 Mexiletini hydrochloridum ...................................................................................................3–4381 Methylcellulosum ............................................................ 2779 Minoxidilum ............................... 2745 Methylis nicotinas ..................................3–4383 Methylergometrini maleas.......... 2737 Methylis parahydroxybenzoas ................................................................................................2–4069 Magnesii acetas tetrahydricus ............................................................... 2794 Moranteli hydrogenotartras ad usum veterinarium.......................................................................................................................................... 2698 Medroxyprogesteroni acetas ..................................................... 8....................................................................... 8....................3–4376 Magnesii subcarbonas levis ....................5-hydricum .................................................................. 1304 Malathionum ............................................................................. 1419 Masticabilia gummis medicata .... ...................................................................................................................................................... 2841 Natrii caprylas ................................................................................................................................................................................ 8................ 2872 Natrii iodohippurati (131I) solutio iniectabilis......................................................................................................................................................................... 2826 Natrii sulfas decahydricus ................................... 1092 Natrii picosulfas............................................................................. 3234 Nicethamidum ....... 8....... 1084 Nonoxinolum 9........... 2893 General Notices (1) apply to all monographs and other texts 5897 ....................................................................... 3236 Niclosamidum monohydricum ............................6–5381 Neostigmini bromidum..6–5337 Natrii selenis pentahydricus ............... 8..................... 2856 Natrii fluoridi (18F) solutio iniectabilis.................................................5–5007 Natrii molybdatis (99Mo) fissione formati solutio ... 2094 Nimesulidum ....................... 2824 Natrii stearylis fumaras ..................................................... 3247 Nitrofuralum.... 8............................................... 3253 Naltrexoni hydrochloridum .............................................6–5382 Nystatinum ... 1082 N-Methylpyrrolidonum ............................................................................ 8............ 3242 Nilutamidum ..... 8...................................6–5383 Naftidrofuryli hydrogenooxalas..................... 1085 Norethisteroni acetas .............................................................. 3258 O Natrii pertechnetatis (99mTc) fissione formati solutio iniectabilis ...............................................................3–4391 Natrii citras..............................................................................................................................................................3–4390 Natrii ascorbas............................................................................................ 2883 Natrii lauroylsarcosinas ad usum externum .....................................................................4–4814 Nicotinum .................................................................................................................................... 2884 Natrii metabisulfis.......................... 2858 Natrii fusidas ...................................................................................................................................... 2844 Natrii carbonas monohydricus ....... 1079 Nicotini resinas.................... 1081 Nitrogenium oxygenio depletum................. 2840 Natrii calcii edetas.................... 3252 Norfluranum.................................................................................................................... 2886 Natrii nitris ....................................................................................................... 8.....6–5339 Natrii chloridum ................ 3254 Nortriptylini hydrochloridum.............................. 2846 Natrii chromatis (51Cr) solutio sterilis ...... 2815 Natrii selenis ...............................................................................................................................3–4389 Natrii aminosalicylas dihydricus . 3232 Nevirapinum anhydricum. 3250 Nitrogenii oxidum ............ 2884 Natrii molybdas dihydricus......................................................................... 2754 Natrii iodidi (131I) capsulae ad usum therapeuticum........................................ 8................................................................................................ 8............ 2863 Natrii iodidi (123I) solutioad radio-signandum...................... 2843 Natrii carbonas decahydricus..........................6–5186 iniectabilis .........................3–4410 Neostigmini metilsulfas...........................................................................2–3984 Natrii acetas trihydricus ................. 2877 Natrii laurilsulfas ........ 3267 Nandroloni decanoas .................. 2839 Natrii bromidum ......... 1091 Myrtilli fructus siccus........................................................................... 8................ 2829 Natrii sulfis heptahydricus . 2859 Natrii glycerophosphas hydricus .......... 2853 Natrii dihydrogenophosphas dihydricus ......... 8........................................ 2814 Natrii salicylas ......................................................................................3–4408 Neohesperidin-dihydrochalconum.........6–5375 Nadololum ......................... 2869 Natrii iodidi (131I) solutio ad radio-signandum.. 3271 Nasalia ..................................................... 3230 Netilmicini sulfas.............. 2854 Natrii carbonas anhydricus...... 8....................... 2822 Natrii stearas ................. 3240 Nifedipinum......................................................................................................................................................................................................................................................................................... 3264 Nadroparinum calcicum ..........4–4791 Natrii sulfis anhydricus .......... 2837 Natrii benzoas.... 3245 Nitrendipinum......................................................................................................................................................................................................................................................................................................................... 3258 Natrii phosphatis (32P) solutio iniectabilis .......................................................... 8............6–5338 Natrii cetylo........................................................... 1333 Natrii nitroprussias ................................................ 1090 Octoxinolum 10........................................ 3251 Noradrenalini tartras ......................... 1086 Norethisteronum ........................................................... 1084 Noradrenalini hydrochloridum ..... 1078 Natrii valproas........ 3226 Neomycini sulfas .......... 8..................................................... 2862 Natrii hyaluronas ................................................................. 1479 Natrii propionas ............ 2864 Natrii iodidi (123I) solutio iniectabilis .............6–5383 Naloxoni hydrochloridum dihydricum ............................... 2831 homoeopathicas .............................4–4813 Nicotini ditartras dihydricus................................. 2875 Natrii lactatis solutio ................ 3235 Niclosamidum anhydricum............................................................................................................. 3244 Nitrazepamum..................5-hydricus ....................................................................................................................................................................................... 3229 Neroli aetheroleum......................................................................................................................................................................................................................... 3269 Naphazolini nitras .........................................................................4–4813 Nevirapinum hemihydricum........................... 2850 Natrii cyclamas................................................................................ 3270 Naproxenum .......................................................................... 8.............................................................6–5175 Nicergolinum ............................................... 3261 N-Acetyltryptophanum................................................................................................ 8............................................................ 8........ 8............................................................................................................7–5826 Natrii thiosulfas.... 1329 Natrii aurothiomalas ........6–5382 Nitrogenium................... 2869 Natrii iodidum......................................................... 1481 Natrii risedronas 2....................................................................................................................................... 8.................................................... 3260 N Nabumetonum........ 3271 Natrii acetatis ([1-11C]) solutio iniectabilis............................ 2845 Natrii cromoglicas ......................................................................................................................................1–3814 Nicotinamidum ..... 1088 Noscapinum . 1087 Norfloxacinum ...................................................................................................... 8...........................................................7–5826 Norgestimatum .................. 3233 Niaouli typo cineolo aetheroleum.......................................................................... 3236 Nicorandilum........... 1079 Nimodipinum ......................................................... 2866 Natrii iodidi (131I) capsulae ad usum diagnosticum................. 2871 Natrii iodohippuras dihydricus ad radiopharmaceutica.................... 3272 Natrii alendronas trihydricus ............................................................................................. 2834 Natrii amidotrizoas...... 8.7 Index Natrii pertechnetatis (99mTc) sine fissione formati solutio Myrtilli fructus recentis extractum siccum raffinatum et normatum .................................................................................................................................. 3270 Naproxenum natricum .....7–5788 Natrii fluoridum......................... 2874 Natrii iodohippurati (123I) solutio iniectabilis....................... 8......... 8.............................. 3241 Nifuroxazidum .......... 2888 Natrii perboras hydricus.................................................. 2863 Natrii hydrogenocarbonas .............................................. 2861 Natrii hydroxidum ...................................................... 8.......... 3248 Nitrofurantoinum.......................................... 3257 Notoginseng radix . 2833 Natrii alginas ............ 2820 Natrii (S)-lactatis solutio .................................................. 792 Natrii tetrachloroauras dihydricus ad praeparationes Nateglinidum .......................................................................................................... 8.................................. 3262 N-Acetyltyrosinum ............................. 2868 Natrii iodidi (131I) solutio..................................................................................................... 2825 Natrii sulfas anhydricus .. 1083 Nomegestroli acetas.............................................. 8........................................................................................................................... 1080 Nizatidinum..................6–5183 Natrii phenylbutyras .................................................................................................................. 3256 Noscapini hydrochloridum hydricum .....................................................................................7–5827 Norgestrelum ............................................................................................ 8....... 8..................................... 2813 Natrii polystyrenesulfonas ............... 3268 Naphazolini hydrochloridum.. 1332 Natrii calcii pentetas ad radiopharmaceutica ............................................................................et stearylosulfas ............EUROPEAN PHARMACOPOEIA 8..................... 2855 Natrii docusas...................... 3024 Phthalylsulfathiazolum........................................................................................................................................ 775 Olibanum indicum.............. 2965 Paraffinum solidum ..... 3011 Phenylephrini hydrochloridum........................................................................................................................................................................................ 3036 Pini pumilionis aetheroleum.................................................................... 3044 Piperis fructus........................ 2971 Passiflorae herba....3–4396 Piperacillinum natricum ..................................................................................... 2966 Paraffinum perliquidum................................................7–5798 Pilocarpini nitras..........................................6–5191 Pethidini hydrochloridum ................................................................... 2911 Omeprazolum magnesicum...........................................................6–5208 Pharmaceutica..................................... 2943 Oxytetracyclini hydrochloridum...2–3966 Piracetamum ..................... 3045 Pirenzepini dihydrochloridum monohydricum........ 3047 Pirfenidonum...... 2975 Penbutololi sulfas ......................................................... 2901 Olsalazinum natricum............................. 3013 Phenylhydrargyri acetas ....... 3020 Phloroglucinolum dihydricum ................ 8............................................................ 2907 Omega-3 acidorum triglycerida.......................... 2924 Oxacillinum natricum monohydricum................................................................................................................................................................. 8...................... 2925 Oxaliplatinum ......................................................................................................... 3014 Phenylephrinum ............. 782 Opii extractum siccum normatum .............................................. 3041 Piperazini adipas.............................................................................. 2903 Omega-3 acidorum esteri ethylici 60..................................... 2985 Pentoxifyllinum ...... 2206 Ofloxacinum ...................................................... 3029 Picotamidum monohydricum ....................................... 8................................................................. 1074 Oxygenium 93 per centum ...............5–4953 Orbifloxacinum ad usum veterinarium .................................... 3046 Piretanidum.. 2977 Penicillaminum . 1342 Orphenadrini citras ..................................................................................7–5795 Permethrinum 25:75 ..................................................................... 1230 Pini sylvestris aetheroleum .....................6–5345 Orphenadrini hydrochloridum ......................................................................................................................................... 2909 Omeprazolum ......................................................... 2922 Ouabainum................ 2969 Paroxetini hydrochloridum hemihydricum ...............................................1–3795 Oxytetracyclinum dihydricum ... 8............ 2986 Pentoxyverini hydrogenocitras................................................... 2236 See the information section on general monographs (cover pages) ..................................................................................................................... 8.. 2996 Persicariae tinctoriae folium......................................... 1335 Olea herbaria ...................................................................2–3967 Ophthalmica ............................ 1363 Paracetamolum .......................... 2962 Papaveris rhoeados flos.. 3022 Pholcodinum............................................................................. 2900 Olmesartanum medoxomilum....... 2896 Oleae folii extractum siccum..................... 2940 Oxygenium................................................................7–5799 Pimobendanum ........................................................................ 2939 Oxycodoni hydrochloridum ................................................. 2968 Paroxetini hydrochloridum anhydricum ..................... 3043 Piperazinum hydricum ................. 3004 Phenolum ............................................................ 3003 Phenolsulfonphthaleinum..... 2938 Oxybutynini hydrochloridum ..................................................................................................................6–5192 Oryzae amylum ........................... 3001 Phenobarbitalum natricum........................................................................................5–4951 Opii pulvis normatus .................................................................. 3030 Pilocarpini hydrochloridum.................................................................................... 3002 Phenolphthaleinum ...............................................................................................6–5355 Pancuronii bromidum ...................................................................................................7–5794 Pentazocini hydrochloridum.............................. 8........... 8.........................2–4085 Phenylbutazonum ................................................ 2934 Oxprenololi hydrochloridum ................................... 8......................................................................................................................... 3015 Phenylhydrargyri boras ........................... 2905 Omega-3 acidorum esteri ethylici 90................................................................................................................................................... 2988 Pepsini pulvis ..........3–4395 Phytosterolum.......................... 8..4–4691 Parnaparinum natricum ................ 2964 Paraldehydum ................................................... 756 Phenazonum ................... 3034 Pindololum .5–5011 Perphenazinum ........................................................................................... 1347 Pefloxacini mesilas dihydricus .............. 8..................................... 8.............................. 3048 Piscis oleum omega-3 acidis abundans .............................. 2968 Parenteralia ................... 3003 Phenoxyethanolum ...... 8................................................................................................................................................................... 2978 Pentaerythrityli tetranitras dilutus............................................... 8....................................................... 2989 Pergolidi mesilas................ 2984 Pentobarbitalum natricum................................ 2997 Petroleum ad praeparationes homoeopathicas............................................................................................................................................... 1337 Oleae folium.... 2949 Oxytocinum .......................................................................................... 8............................................... 2959 Pantoprazolum natricum sesquihydricum ........ 2929 Oxcarbazepinum .............. 2894 Octylis gallas ............... 8................ 8.........................................................................6–5350 Oxfendazolum ad usum veterinarium............................................ 2953 Pancreatis pulvis............. 3000 Phenobarbitalum.............................................................................................. 2915 Ononidis radix...................................................................................................................................................................................................................... 8.......................... 2983 Pentazocini lactas.. 2941 Oxygenium (15O) ................................................................................................... 3017 Phenytoinum ............................................................................................................... 3006 Phenoxymethylpenicillinum kalicum ........................................................................................................ 2899 Olivae oleum virginale............................................................................................................................................................... 2984 Pentazocinum ............................................... 2893 Oenotherae oleum raffinatum...............................7–5797 Phenylalaninum .............................................. 1276 Olivae oleum raffinatum ...... 8....................................................................................................Index Octyldodecanolum ..................................................... 8.............................. 8.............................................................................................................................................................................................................................................................................................................................5–4955 Opium crudum ............................................ 2948 P Paclitaxelum ............... 3026 Physostigmini salicylas .................................... 3007 Phentolamini mesilas........ 2918 Origani herba ................. 1349 Piperis longi fructus .. 1355 Pioglitazoni hydrochloridum ............... 1347 5898 EUROPEAN PHARMACOPOEIA 8....7–5793 Pelargonii radix ........... 8.............................................................................................. 8............................................... 8..................................................... 8.................................. 1348 Pemetrexedum dinatricum heptahydricum.................... 2912 Omeprazolum natricum .....................................................6–5347 Oxazepamum ...........................6–5359 Piroxicamum .................. 2942 Oxymetazolini hydrochloridum............................................... 8.......................................5–4952 Opii tinctura normata ........................................................ 8.................................................................................................................... 2982 Pentobarbitalum . 3017 Phenytoinum natricum........................................................................................ 3027 Phytomenadionum.................... 3016 Phenylpropanolamini hydrochloridum......................................................................6–5357 Pheniramini maleas ..... 2931 Oxeladini hydrogenocitras ............. 8................................................................................................................. 8............................... 3005 Phenoxymethylpenicillinum............................................ 3033 Pimozidum........................... 2933 Oxitropii bromidum............................................... 3016 Phenylhydrargyri nitras......................... 8..... 3037 Piperacillinum ................................................................................................................................................................... 3019 Phloroglucinolum anhydricum ......................................................7 Passiflorae herbae extractum siccum....................................... 2960 Papaverini hydrochloridum ................................ 2913 Ondansetroni hydrochloridum dihydricum ...................................................................................... 2963 Paraffinum liquidum .................................... 2895 Olanzapinum............................6–5346 Orthosiphonis folium ....... 3042 Piperazini citras......... 2980 Pentamidini diisetionas ....................................4–4806 Oseltamiviri phosphas .................. 2916 Orciprenalini sulfas..................... 2945 Oxytocini solutio concentrata .............................. 2937 Oxybuprocaini hydrochloridum ....................... ............................. 1186 Riboflavini natrii phosphas .................................. 8... 3131 Pyridostigmini bromidum .............. 799 Pyranteli embonas....3–4249 Rectalia.......... 8............................................................................................. 8...................................................... 3135 Q Quercus cortex .................................................................................... 8..... 3115 Propranololi hydrochloridum ................................................................... 787 Praeparationes intra-uterinae ad usum veterinarium ....................................................................... 786 Praeparationes intraruminales ............................................. 1076 Radiopharmaceutica ............................................................... 1382 Polygoni avicularis herba ...................... 758 Producta allergenica ................................................ 3102 Procaini hydrochloridum ............................................................ 3050 Pivmecillinami hydrochloridum ............................................. 805 Praeparationes buccales.............................. 3055 Polyoxypropyleni aether stearylicus ......................................................................4–4805 Raclopridi ([11C]methoxy) solutio iniectabilis .............................................. 8...................... 8.. 3128 Prunellae spica....... 3054 Poly(alcohol vinylicus)....................... 3159 Ribis nigri folium..... 805 Pramipexoli dihydrochloridum monohydricum .................................................................................................................... 3118 Propylis gallas ................................ 1287 Polygoni multiflori radix ............................................................................................... 3156 Reserpinum ............................................................................................................ 8.....................................3–4399 Prilocainum ............................................................................. 746 Plantae medicinales ad praeparationes homoeopathicas ...........1–3807 R Rabeprazolum natricum.................................... 1202 Rhei radix... 3082 Pravastatinum natricum ................................................ 3101 Primulae radix....... 1245 Polymyxini B sulfas.................. 1288 Puerariae thomsonii radix ...................................... 8................................................................................................................................................1–3802 Protamini sulfas .........................................................3–4398 Primaquini diphosphas...........5–5018 General Notices (1) apply to all monographs and other texts Index Proguanili hydrochloridum.............................................................................................7 Pisi amylum ..............................................................................................6–5360 Polysorbatum 20............... 806 Repaglinidum.............................................................................................................................................................................................. 3132 Pyridoxini hydrochloridum.............................................................. 746 Plantaginis lanceolatae folium........ 747 Plantae medicinales ....... 8..... 759 Progesteronum......................................................................... 3112 Propanolum ................................ 3125 Prothrombinum multiplex humanum ................ 8...................................... 8.............. 3127 Proxyphyllinum ........................................................................................................ 3106 Prolinum ..............7–5801 Prilocaini hydrochloridum . 799 Pulveres perorales.................................................................. 8................................................................................... 748 Praeparationes homoeopathicae ........................... 8.............................................................. 3134 Pyrrolidonum ..... 2425 Plasma humanum coagmentatum conditumque ad exstinguendum virum.............. 3061 Poria ........................................... 3086 Prazosini hydrochloridum...................................................................................................... 3091 Prednisoloni natrii phosphas ......................................................... 1782 5899 ........................................................ 3124 Propyphenazonum ............................................................. 3158 Rhamni purshianae cortex ................... 807 Praeparationes molles veterinariae peroraliae ................................... 3121 Propylenglycolum ....................2–4091 Quillajae cortex ................................ 789 Praeparationes liquidae peroraliae..........5–5012 Polyacrylatis dispersio 30 per centum ......................................................... 8...1–3801 Propanthelini bromidum.............. 1281 Plantarum medicinalium extracta .. 3051 Plantae ad ptisanam ............................. 8............................................................................................................................................ 763 Producta ab fermentatione..............................................................................................5–5013 Polysorbatum 40.............................................................. 8....................... 800 Praeparationes ad irrigationem ................................... 3094 Prednisoloni pivalas........ 8................................................................................................................ 3133 Pyrimethaminum .. 3122 Propylis parahydroxybenzoas natricus ........... 3150 Ramiprilum. 3155 Ratanhiae radix..3–4353 Poloxamera ..................................... 3103 Prochlorperazini maleas ................... 3090 Prednisonum.................................................... 3099 Primidonum ...................... 8....................... 8.............................. 814 Praeparationes molles ad usum dermicum.. 8......................................................................2–3945 Producta cum possibili transmissione vectorium enkephalopathiarum spongiformium animalium.............. 3104 Producta ab arte ADN recombinandorum............................................................................................................................................................................................................................................................... 3129 Psyllii semen............. 8.......... 1429 Plantae medicinales praeparatae................................................... 3107 Promazini hydrochloridum......................EUROPEAN PHARMACOPOEIA 8............3–4263 Praeparationes insulini iniectabiles......... 1356 Probenecidum...... 3119 Propylenglycoli monolauras ............................ 3114 Propofolum .................................................................................................................. 1356 Povidonum.....................................................................................7–5800 Polygalae radix .......................................................... 3083 Prazepamum........................ 1094 Ribavirinum......... 3110 Propafenoni hydrochloridum..........6–5361 Poly(vinylis acetas).... 8.............................. 1367 Plantaginis ovatae semen ......................................................................................................... 3093 Prednisolonum .... 3157 Resorcinolum ........7–5812 Rapae oleum raffinatum..............................5–4915 Plasma humanum ad separationem ................................................................. 2429 Protirelinum .......... 3120 Propylenglycoli monopalmitostearas........................................................................................3–4248 Pseudoephedrini hydrochloridum ................................................................ 1335 Quetiapini fumaras ............. 3109 Propacetamoli hydrochloridum .6–5364 Propylenglycoli dilauras ...................7–5808 Racecadotrilum .................5–5014 Polysorbatum 60......................... 759 Raloxifeni hydrochloridum .....1–3799 Prednisoloni acetas........ 1366 Rhenii sulfidi colloidalis et technetii (99mTc) solutio iniectabilis ......................................................... 8...................5–5017 Praziquantelum.............................................................................. 8................... 3117 Propylenglycoli dicaprylocapras...............6–5303 Praeparationes intramammariae ad usum veterinarium..........................................................................................3–4248 Ratanhiae tinctura ................................................................... 8......................................... 3121 Propylis parahydroxybenzoas .......................................................................................................................... 787 Praeparationes liquidae ad usum dermicum................................................ 1201 Rhamni purshianae extractum siccum normatum ........................ 8................... 3130 Pyrazinamidum.......................................................................................................................................... 3108 Promethazini hydrochloridum......................... 8.................................. 8.......................................7–5807 Rabeprazolum natricum hydricum ................................................ 1282 Plantaginis ovatae seminis tegumentum..........................................3–4400 Procainamidi hydrochloridum..............................5–5016 Poly(vinylis acetas) dispersio 30 per centum ................................................................................................................................................. 8.. 1362 Quinaprili hydrochloridum...................5–5015 Polysorbatum 80........................................................................................ 8............. 3087 Prednicarbatum........... 8......1–3799 Pivampicillinum ..............7–5810 Ranitidini hydrochloridum ........3–4404 Pulveres ad usum dermicum............................................. 3162 Riboflavinum ................................................................ 8.................................. 8................................................................................................ 8............................... 1219 Pruni africanae cortex ............... 3095 Pregabalinum ....................... 1402 Pullulanum ........................................................................................................... 793 Praeparationes celeres ad ptisanam ..................................................6–5363 Praeadmixta ad alimenta medicata ad usum veterinarium................................1–3689 Praeparationes pharmaceuticae in vasis cum pressu....................................... 8.................................. 8...... 1357 Puerariae lobatae radix ....................................... 3078 Povidonum iodinatum......................... 3160 Ricini oleum hydrogenatum................................................................ 8..................................................................................................................... 790 Praeparationes liquidae veterinariae ad usum dermicum ................................................................................................... 3263 Propylthiouracilum ........ ........................................... 8. 2378 Solutiones ad haemodialysem ..................................3–4407 Saccharinum natricum .................. 8............................... 8.......... 3195 Salbutamolum .......................... 3283 Sorbitani trioleas .... 2994 Solutiones anticoagulantes et sanguinem humanum conservantes........7–5820 Schisandrae chinensis fructus............................................................................................................6–5218 Somatostatinum ..........................6–5391 Sulfadiazinum .......................................... 3165 Rifamycinum natricum . 3298 Squalanum.............2–4097 Rifaximinum............................................................... 8........................................................................... 3289 Soiae oleum raffinatum ............................... 3179 Rocuronii bromidum .......................5–5023 Rilmenidini dihydrogenophosphas .... 3292 Spicae aetheroleum ............6–5376 Rivastigminum . 3219 Silica colloidalis anhydrica......................... 3187 S Sabalis serrulatae extractum ..................................... 3201 Salviae lavandulifoliae aetheroleum ................................................. 3183 Rosae pseudo-fructus ................ 8............................................................................................... 2462 Scopolamini hydrobromidum ................................................................................ 3437 RRR-α-Tocopherylis acetas ........................................................................ 8..........................6–5387 Spironolactonum .....................................................................................................................................7–5823 Soiae oleum hydrogenatum................................................. 8.............................. 3222 Simvastatinum..................... 2461 Scutellariae baicalensis radix ............................. 3185 RRR-α-Tocopherolum...................................................................................................................... 8................. 3325 Sulbactamum natricum............................................ 8....... 1422 Salicis corticis extractum siccum ... 3210 Serum bovinum .......................................... 1397 Stramonii pulvis normatus........................ 1399 Streptokinasi solutio concentrata.... 3315 Streptomycini sulfas ........ 1192 Rutosidum trihydricum ....................... 3173 Rivastigmini hydrogenotartras ................................................................... 8................................. 3181 Ropiniroli hydrochloridum.............................. 1161 Selamectinum ad usum veterinarium.................................................................................................................................2–3974 Sertaconazoli nitras ............. 1092 Strychnos ignatii ad praeparationes homoeopathicas..................................................................3–4250 Salviae sclareae aetheroleum ................................................................................. 3208 Serpylli herba ....... 8.............4–4816 Stanni colloidalis et technetii (99mtc) solutio iniectabilis.............................................. 1423 Salmeteroli xinafoas.....................5–5028 Sulfacetamidum natricum....................................................................... 1379 Sacchari monopalmitas ........................ 8............................................. 1376 Saquinaviri mesilas ............... 3284 Sorbitolum ................................................................................................. 3282 Sorbitani palmitas................................................................................ 1374 Salviae officinalis folium ......................... 3164 Rifampicinum .................................... 3288 Spectinomycini dihydrochloridum pentahydricum ........... 8............................................................................................ 8................................ 8............................................................................................................................ 3207 Semecarpus anacardium ad praeparationes homoeopathicas ................................................................................................................................................ 8.....2–3981 Sennae folii extractum siccum normatum ......3–4253 Serinum ...........................7–5822 Sildenafili citras.. 8. 1265 Solifenacini succinas ....... 8........................ 1109 Stannosi chloridum dihydricum ................. 3217 5900 EUROPEAN PHARMACOPOEIA 8............... 3319 Sufentanili citras ..... 8...........................3–4256 Sorbitani lauras .............................................................. 1370 Rosmarini folium ........................... 8......1–3706 Solidaginis virgaureae herba....................................................................... 3176 Rizatriptani benzoas ................................................................................................................5–4956 Sennae folium .. 1246 Stramonii folium . 8................................. 8..................6–5389 Salbutamoli sulfas ................................................................................................................................................... 8................................................................... 1377 Sabalis serrulatae fructus....................................................................................................................................................... 3220 Silybi mariani extractum siccum raffinatum et normatum........................................1–3813 Salmonis domestici oleum ....7–5814 Ropivacaini hydrochloridum monohydricum ............................ 3223 Sinomenii caulis ............................................... 1232 Sanguisorbae radix...............................3–4281 Ricini oleum virginale............... 3273 Solutiones ad haemocolaturam haemodiacolaturamque .............3–4413 Stephaniae tetrandrae radix....6–5390 Sacchari stearas ..............................................................................................3–4254 Sophorae japonicae flos immaturus ............................... 8............................................................................................................................................................................................ 1321 Simeticonum ..............2–4101 Selenii disulfidum.................................. 3282 Sorbitani oleas ........................................................................................................................ 809 Sucralfatum. 3193 Salicis cortex ............................................................................................................... 8................................................................ 1686 Sesami oleum raffinatum .............7–5830 Sorbitolum liquidum cristallisabile ............................................................................................................................................ 8................ 3318 Sucralosum........ 3169 Risperidonum ............................ 3317 Strontii (89Sr) chloridi solutio iniectabilis ................................................................................................................ 8.................................................3–4252 Sennae fructus angustifoliae.................... 3322 Saccharinum ........................ 3282 Sorbitani sesquioleas .......................................4–4807 Roxithromycinum ...............4–4816 Sorbitolum liquidum partim deshydricum ........................................................................................................................7–5824 Sitagliptini phosphas monohydricum............... 3323 Saccharum .............................................................................................................................. 1213 Salviae tinctura .... 8................................... 3171 Ritonavirum.................................. 8... 3218 Silica colloidalis hydrica ................................... 1320 Silybi mariani fructus ..........................................................3–4270 Styli ....................... 3326 Sufentanilum ................................................................................ 8.......................... 3302 Stanozololum ....2–3970 Sambuci flos........................................... 3283 Sorbitani stearas ............................................................ 1390 Spiramycinum .1–3816 Somatropini solutio concentrata........ 3443 Rusci rhizoma ............................... 8...................... 8........................................6–5386 Somatropinum...........................Index Ricini oleum raffinatum ...................................................... 3302 Stavudinum..................................4–4763 Solutiones ad peritonealem dialysem .. 1381 Scopolamini butylbromidum .......................................................................................................... 1389 Salviae miltiorrhizae radix et rhizoma ..................... 8... 2464 Scopolaminum.................................3–4251 Sennae fructus acutifoliae ... 3275 Somatropinum iniectabile ...................................................... 8........................................................................................................................................ 3212 Sevofluranum.................................................................................................... 8. 1374 Salviae trilobae folium........................... 1344 Sitagliptini compressi ..................................7–5819 Sacchari sphaerae.............................................. 3294 Spiraprili hydrochloridum monohydricum ................................3–4408 Silica hydrophobica colloidalis.....................................................................6–5384 Solutiones ad conservationem partium corporis.............................. 3290 Solani amylum ....... 3439 RRR-α-Tocopherylis hydrogenosuccinas....... 3290 Spectinomycini sulfas tetrahydricus ad usum veterinarium .......................................5–5027 Selegilini hydrochloridum ................................ 1369 Rosuvastatinum calcicum............................................................. 8......................... 8.........................7 Silica ad usum dentalem ....3–4417 See the information section on general monographs (cover pages) ................. 8. 3287 Sotaloli hydrochloridum ........................................................ 8........... 3331 Sulfadimethoxinum............. 3277 Somatropini solutio iniectabilis ...................................................................................................... 3209 Sertralini hydrochloridum.............................................................................................................................. 3279 Sophorae japonicae flos ...................................................................................................................................... 8...... 3078 Solidaginis herba .............................. 1228 Rosmarini aetheroleum ......................................................................................................................................... 8....................... 8......................................... 1095 Stanni pyrophosphatis et technetii (99mTc) solutio iniectabilis ............. 8........................ 8..............................................................................3–4282 Rifabutinum....................................... 8.................................3–4268 Strychnos nux-vomica ad praeparationes homoeopathicas ........................... 8.................................................4–4815 Sorbitolum liquidum non cristallisabile.......... ........................................................................... 3367 Telmisartanum.................. 3407 Thioridazini hydrochloridum .......................... 3450 Toxinum botulinicum A ad iniectabile......... 1684 Tragacantha..........................................................6–5398 Thiamphenicolum ... 8...................4–4824 Torasemidum anhydricum..... 8....................................... 3344 Sulfuris colloidalis et technetii (99mTc) solutio iniectabilis.............. 3423 Ticlopidini hydrochloridum ...............................6–5399 Thiocolchicosidum ex ethanolo cristallisatum................................................................................... 8............................... 3421 Ticarcillinum natricum.. 3383 Testosteroni isocaproas .. 1105 Technetii (99mTc) oxidronati solutio iniectabilis .................................................................2–3971 Thymi typo thymolo aetheroleum .... 8................................ 8.............................7–5837 Tamponae medicatae .......................1–3823 Tibolonum.......................1–3818 Sultamicillini tosilas dihydricus........................................................................ 3377 Terconazolum.............................................. 8....................................... 3354 Suxibuzonum......................................................................... 3398 Theophyllinum et ethylenediaminum hydricum....................................................................1–3715 Tinidazolum.............. 8........................... 3424 Tiliae flos ........................................................................................................ 1111 General Notices (1) apply to all monographs and other texts Index Theobrominum............................................................................................................ 3345 Sulpiridum ....................... 8.................. 3433 Tizanidini hydrochloridum .................. 8............ 8.................................... 8....................... 3409 Threoninum................................ 3416 Tiamulinum ad usum veterinarium................................. 3449 Tormentillae rhizoma .. 3335 Sulfamerazinum ....... 1407 Tosylchloramidum natricum ...................................................... 3462 Triamcinolonum ................................................ 1405 Thymolum............................................................... 3414 Tianeptinum natricum ................................... 3334 Sulfaguanidinum............. 1223 Taraxaci officinalis radix.... 3472 Trigonellae foenugraeci semen............................................................................... 1456 Sulfur ad usum externum.................................................................................................................................................... 3456 Tretinoinum.......... 812 Tamsulosini hydrochloridum ....................................................................... 3340 Sulfasalazinum ..................................... 3452 Trandolaprilum......................... 3426 Timololi maleas .......... 1093 Technetii (99mTc) et etifenini solutio iniectabilis............... 3471 Triglyceroli diisostearas ..................................... 8.............................................................................................. 3453 Trapidilum............................... 3427 Tincturae maternae ad praeparationes homoeopathicas ........................................................................................ 3412 Tiabendazolum .............................. 1106 Technetii (99mTc) sestamibi solutio iniectabilis ............. 3386 Testosteronum ........................................................................................ 3371 Tenoxicamum.............. 3430 Tioconazolum ..7–5840 Thiomersalum ................................................ 3459 Triamcinoloni acetonidum ................................................................................................... 3429 Tinzaparinum natricum . 3396 Thiamazolum ... 3378 Terebinthinae aetheroleum .......................... 1295 Tilidini hydrochloridum hemihydricum ................ 3458 Triacetinum ................................................. 3390 Tetra-O-acetylmannosi triflas ad radiopharmaceutica....................................................... 3355 T Tadalafilum.... 3406 Thiopentalum natricum et natrii carbonas ............................................... 1110 Tetrazepamum ........................................................................................................ 3369 Temazepamum................................7–5832 Sultamicillinum.......................................................................................................................................... 8.......................... 1408 Tramadoli hydrochloridum......................................................7–5679 Technetii (99mTc) pentetatis solutio iniectabilis ........................................................................................................................................... 3468 Trifluoperazini hydrochloridum........................................................................................................................................................................................................... 1100 Technetii (99mTc) mebrofenini solutio iniectabilis ................. 3431 Titanii dioxidum .. 8................................................. 3343 Sulfur ad praeparationes homoeopathicas.............................................. 3410 Thioridazinum .......... 3463 Tribenosidum .......... 8....................................................................... 3385 Testosteroni propionas........................ 3470 Triglycerida saturata media..............................................................................................................................6–5395 Theophyllinum monohydricum .... 3352 Suxamethonii chloridum ..............................6–5400 Tributylis acetylcitras................................... 3380 Tetracaini hydrochloridum ............................................ 3359 Talcum.......... 3391 Tetracyclinum........ 8.................7–5838 Thiocolchicosidum hydricum ............................................................................................ 3393 Tetryzolini hydrochloridum ....................................................................... 3434 α-Tocopherylis acetatis pulvis ............................................................................ 8.. 1101 Technetii (99mTc) medronati solutio iniectabilis ............................... 1244 Tanninum .............................................. 8............................................................................................................................................... 3364 Tanaceti parthenii herba ................................................................. 1107 Technetii (99mTc) succimeri solutio iniectabilis................ 1097 Technetii (99mTc) gluconatis solutio iniectabilis.................. 1683 Toxinum botulinicum B ad iniectabile .................................. 2991 Testosteroni decanoas .................... 3387 Tetracosactidum....................................................................................................................... 3373 Terbinafini hydrochloridum .................. 8..... 3337 Sulfamethoxazolum .............................................1–3817 Sulfadoxinum .........................................................................................................................................................................................EUROPEAN PHARMACOPOEIA 8.................................4–4701 Technetii (99mTc) exametazimi solutio iniectabilis.......................... 3473 Trimebutini maleas............................. 3474 5901 ............................................................................................................................... 3395 Theophyllinum et ethylenediaminum anhydricum ................. 3441 Tolbutamidum .................................................................. 3418 Tiapridi hydrochloridum .................................... 3375 Terbutalini sulfas .....................................2–3973 Terfenadinum............................................. 3411 Thymi herba . 3447 Tolterodini tartras.................................................................................................................................................................................................... 3338 Sulfamethoxypyridazinum ad usum veterinarium....................................................................................... 3455 Trehalosum dihydricum ............... 3339 Sulfanilamidum................................................... 1108 Teicoplaninum................................ 3361 Tamoxifeni citras...................................3–4418 Sulfadimidinum.......... 3445 Tolnaftatum........................................................................................ 3336 Sulfamethizolum ........5–5033 Triethylis citras.................... 3413 Tiamulini hydrogenofumaras ad usum veterinarium ......................................................................................................................... 1749 Triclabendazolum ad usum veterinarium............................................................................................................ 8............ 3334 Sulfafurazolum ..............7 Sulfadimethoxinum natricum ad usum veterinarium.........6–5177 Technetii (99mTc) mertiatidi solutio iniectabilis................. 3366 Taraxaci officinalis herba cum radice ........................................... 3340 Sulfathiazolum.......... 3460 Triamcinoloni hexacetonidum ...................................... 3401 Thiamini hydrochloridum....... 1407 Tormentillae tinctura...3–4423 Theophyllinum ................................... 3469 Triflusalum ...................................................................................... 3394 Thallosi (201Tl) chloridi solutio iniectabilis ........................... 3379 tert-Butylamini perindoprilum..4–4823 Tobramycinum ... 1095 Sulindacum ................................................................. 3450 Tramazolini hydrochloridum monohydricum ............... 8..................................... 3382 Testosteroni enantas .................... 3459 Triamterenum ....... 3348 Sumatriptani succinas ....... 1244 Trihexyphenidyli hydrochloridum.................................................................. 3342 Sulfinpyrazonum ......................................................................... 3388 Tetracyclini hydrochloridum.......................................................................................................................................................................................................... 1104 Technetii (99mTc) microsphaerarum suspensio iniectabilis ................................................................................................................................................... 1224 Technetii (99mTc) bicisati solutio iniectabilis........................... 8... 1098 Technetii (99mTc) humani albumini solutio iniectabilis............................ 3466 Tricalcii phosphas ........................................................................................................................................................................................................................................................... 3372 Terazosini hydrochloridum dihydricum ....................... 8........................................................................................................................................6–5396 Thiamini nitras . 1099 Technetii (99mTc) macrosalbi suspensio iniectabilis........ 3430 Tiotropii bromidum monohydricum ................................. .... 3485 Trospii chloridum........................................................................................................................ 952 Vaccinum Clostridii chauvoei ad usum veterinarium......... 8......... 823 Vaccinum diphtheriae et tetani.......................................................6–5169 Vaccinum bursitidis infectivae aviariae inactivatum ................. 8...... 8.............................. 931 Vaccinum erysipelatis suillae inactivatum..... 3563 Tritici aestivi oleum virginale ................................................. hepatitidis B (ADNr)........................................ antigeni-o(-is) minutum........ 3510 Urtica dioica ad praeparationes homoeopathicas................................. 840 Vaccinum encephalitidis ixodibus advectae inactivatum......................................................................... 936 Vaccinum bronchitidis infectivae aviariae inactivatum......... 3486 Troxerutinum ....................... 8..................................................................... 3488 Trypsinum...... 3564 Tritici amylum .. 835 Vaccinum diphtheriae.............................................................................. tetani et pertussis sine cellulis ex elementis praeparatum................................................................. 8............................................................... 945 Vaccinum anaemiae infectivae pulli vivum ................... 954 Vaccinum Clostridii perfringentis ad usum veterinarium ........ adsorbatum .............................. 925 Vaccinum bronchitidis infectivae aviariae vivum. antigeni-o(-is) minutum........................3–4222 Vaccinum diphtheriae et tetani adsorbatum ......................... 8......... antigeniis minutum...................................... tetani....... 994 5902 EUROPEAN PHARMACOPOEIA 8..3–4221 Vaccinum diphtheriae....................................7–5843 Tri-n-butylis phosphas................................................................. 984 Vaccinum anthracis adsorbatum ab colato culturarum ad usum humanum ................ tetani....5–4923 Vaccinum hepatitidis A inactivatum adsorbatum et febris typhoidis polysaccharidicum........................................... 1018 Vaccinum febris flavae vivum ............................ 941 Vaccinum diphtheriae adsorbatum ......................... 944 Vaccinum influenzae equinae inactivatum ................................................ antigeni-o(-is) minutum... 992 Vaccinum diarrhoeae viralis bovinae inactivatum.. 3500 Tylosinum ad usum veterinarium................7–5674 Vaccinum febris typhoidis vivum perorale (stirpis Ty 21a) .................. 3507 Ureum .......... 967 Vaccinum inactivatum diarrhoeae vituli coronaviro illatae.......... antigeni-o(-is) minutum............... 970 Vaccinum calicivirosis felinae vivum ............ tetani et hepatitidis B (ADNr) adsorbatum................ 928 Vaccinum bursitidis infectivae aviariae vivum ..................................................... 921 Vaccinum aphtharum epizooticarum inactivatum ad ruminantes.................. 3563 Trolaminum.. 3477 Trimipramini maleas........................3–4232 Vaccinum haemophili stirpi b et meningococcale classis C coniugatum .................................... 8... 972 Vaccinum cholerae ................ 3493 Tuberculini bovini derivatum proteinosum purificatum.......2–3951 Vaccinum diphtheriae...................................... 826 Vaccinum diphtheriae............................. 3481 Trometamolum.................................... 8.................... 3498 Tylosini tartras ad usum veterinarium. tetani et poliomyelitidis inactivatum..................... pertussis sine cellulis ex elementis praeparatum et hepatitidis B (ADNr) adsorbatum ..................................... 8.................................................. 1000 Vaccinum adenovirosidis caninae vivum .................................................... 770 Vaccinum actinobacillosidis inactivatum ad suem..........3–4423 Tuberculini aviarii derivatum proteinosum purificatum . 3509 Urokinasum .... 914 Vaccinum febris typhoidis ............................................ 8........... 844 Vaccinum diphtheriae.................................. adsorbatum........... 830 Vaccinum diphtheriae................... 827 Vaccinum diphtheriae.... 957 Vaccinum coccidiosidis vivum ad pullum.... 8........7 Vaccinum colibacillosis fetus a partu recentis inactivatum ad suem .............................3–4231 Vaccinum Bordetellae bronchisepticae vivum ad canem ............................................................................................................... 865 Vaccinum influenzae inactivatum ex cellulis virisque integris praeparatum ...................... poliomyelitidis inactivatum et haemophili stirpis b coniugatum adsorbatum....................................................... 3475 Trimethadionum ............................ 955 Vaccinum Clostridii septici ad usum veterinarium ............................ 964 Vaccinum herpesviris equini inactivatum .... 3467 Tritici aestivi oleum raffinatum........7–5666 Vaccinum hepatitidis A inactivatum adsorbatum ................................................................................................ 8. 908 Vaccinum encephalomyelitidis infectivae aviariae vivum .......................... 968 Vaccinum influenzae inactivatum ad suem ............................... 821 Vaccinum cholerae aviariae inactivatum ........ 8.................. adsorbatum.......Index Trimetazidini dihydrochloridum........ 8..6–5401 Tryptophanum......... pertussis sine cellulis ex elementis praeparatum................ poliomyelitidis inactivatum et haemophili stirpis b coniugatum adsorbatum........7–5695 Uvae ursi folium . tetani. tetani et pertussis ex cellulis integris adsorbatum.......................... tetani...........................................1–3694 Vaccinum colibacillosis fetus a partu recentis inactivatum ad ruminantes........................................................................................................................................ 3476 Trimethoprimum ...................................................... tetani et pertussis sine cellulis ex elementis praeparatum adsorbatum ..................................................................................................................................................... pertussis sine cellulis ex elementis praeparatum et poliomyelitidis inactivatum... 3502 U Ubidecarenonum. 8....................... 911 Vaccinum febris typhoidis polysaccharidicum...................................................................... pertussis ex cellulis integris.............. pertussis sine cellulis ex elementis praeparatum et poliomyelitidis inactivatum adsorbatum ........ 911 Vaccinum febris typhoidis cryodesiccatum ...................................... 3483 Tropisetroni hydrochloridum. 1331 Urticae radix................................................................ 3483 Tropicamidum......................... 926 Vaccinum brucellosis (Brucella melitensis stirps Rev. 857 Vaccinum hepatitidis viralis anatis stirpis I vivum ............................. 825 Vaccinum diphtheriae. poliomyelitidis inactivatum et haemophili stirpis b coniugatum adsorbatum..... 8...................................... 3494 Tuberculini derivatum proteinosum purificatum ad usum humanum ................................................................................. adsorbatum....................................5–4929 Vaccinum furunculosidis inactivatum ad salmonidas cum adiuvatione oleosa ad iniectionem .......................7–5665 Vaccinum haemophili stirpis b coniugatum .......................................... pertussis sine cellulis ex elementis praeparatum et haemophili stirpis b coniugatum adsorbatum...................................................... 3495 Tuberculinum pristinum ad usum humanum ... 1) vivum ad usum veterinarium ...... 832 Vaccinum diphtheriae.................................. tetani..............2–4105 Tyrothricinum ............................................................... 822 Vaccinum Clostridii botulini ad usum veterinarium ........................ 929 Vaccinum calicivirosis felinae inactivatum ....... 829 Vaccinum diphtheriae.................................................. 943 Vaccinum inactivatum diarrhoeae vituli rotaviro illatae .......................................5–4924 Vaccinum hepatitidis B (ADNr) .........................5–4921 Vaccinum hepatitidis A inactivatum et hepatitidis B (ADNr) adsorbatum.... tetani............ 971 Vaccinum chlamydiosidis felinae inactivatum ........................................................................ 3497 Tyrosinum........ 834 Vaccinum diphtheriae......................................... adsorbatum........... 8................ 837 Vaccinum diphtheriae... 870 See the information section on general monographs (cover pages) ................2–3991 Urticae folium.................................................... tetani................................................................................ 980 Vaccinum cholerae cryodesiccatum ....................................... 8............... 3508 Urofollitropinum ... 767 Vaccina ad usum veterinarium...... 953 Vaccinum Clostridii novyi B ad usum veterinarium........................................................... tetani............... pertussis sine cellulis ex elementis praeparatum.......................... 821 Vaccinum cholerae perorale inactivatum ...5–4922 Vaccinum hepatitidis A inactivatum virosomale ................ 3492 Tylosini phosphatis solutio ad usum veterinarium.................................................................................................. 817 Vaccinum anthracis vivum ad usum veterinarium ............................................................................................................... 946 Vaccinum adenovirosis caninae inactivatum...... 1162 V Vaccina ad usum humanum ....... 8................................................................................... 1003 Vaccinum influenzae inactivatum ex cellulis corticisque antigeniis praeparatum ............. 846 Vaccinum diphtheriae......................... pertussis ex cellulis integris et poliomyelitidis inactivatum adsorbatum.......... 842 Vaccinum diphtheriae...................................... 8.................................... 8....................... .................. 989 Vaccinum morbi partus diminutionis MCMLXXVI inactivatum ad pullum.................. 2967 Vecuronii bromidum ............................................................................. 938 Vaccinum viri syncytialis meatus spiritus bovini vivum................. 1012 General Notices (1) apply to all monographs and other texts Index Vaccinum Salmonellae Enteritidis vivum perorale ad pullum ..................... 3580 5903 .......... 8................. 883 Vaccinum pertussis sine cellulis copurificatum adsorbatum.............. 1013 Vaccinum Salmonellae Typhimurium inactivatum ad pullum ............. 8.............. 3541 Violae herba cum flore........... 3544 Vitaminum A syntheticum densatum oleosum ............................7–5667 Vaccinum meningococcale polysaccharidicum................ solubilisatum densatum in aqua dispergibile .................... 3575 Xenoni (133Xe) solutio iniectabilis .................................................................................................................... 3532 Verbasci flos .............................. 3548 W Warfarinum natricum..... 962 Vaccinum morbi haemorrhagici cuniculi inactivatum....... 1019 Vaccinum pneumococcale polysaccharidicum........... 867 Vaccinum influenzae inactivatum ex viris integris praeparatum ................................. 3579 Xylosum...... 1024 Vaccinum viri parainfluenzae bovini vivum .... 880 Vaccinum pestis anatis vivum..................................................... 3527 Vardenafili hydrochloridum trihydricum ............................................................................................................................................... 891 Vaccinum pseudopestis aviariae inactivatum ................................................... 3517 Valacicloviri hydrochloridum hydricum............................................. 1008 Vaccinum rabiei perorale vivum ad vulpem et nyctereutem ..............................7–5669 Vaccinum morbi Aujeszkyi ad suem inactivatum .... 1293 Verbenae herba..................................2–3974 Valerianae radix..................................................................................................................EUROPEAN PHARMACOPOEIA 8...............................1–3829 Warfarinum natricum clathratum.. 1016 Vaccinum tenosynovitidis viralis aviariae vivum ... 932 Vaccinum leptospirosis bovinae inactivatum ............ 8................. 1001 Vaccinum poliomyelitidis inactivatum ....... 935 Vaccinum tetani adsorbatum........................................................................................................3–4429 Valnemulini hydrochloridum ad usum veterinarium ..... 868 Vaccinum influenzae inactivatum ex virorum fragmentis praeparatum .......................................... 903 Vaccinum vibriosidis aquae frigidae inactivatum ad salmonidas ... 8.......................................... 976 Vaccinum rhinotracheitidis viralis felinae vivum ........ parotitidis et rubellae vivum .......................... 8........................................... 8............... 965 Vaccinum Mycoplasmatis galliseptici inactivatum ................................ 8..............7–5670 Vaccinum pneumoniae enzooticae suillae inactivatum .................... 3521 Valsartanum ............... 8... 879 Vaccinum parvovirosis caninae inactivatum ......... 8............7–5673 Vaccinum pneumococcale polysaccharidicum coniugatum adsorbatum................................................................................................................................................................. 3525 Vanillinum .......................................6–5197 Vigabatrinum............... 819 Vaccinum varicellae vivum .......................................................... 1417 Via praeparandi stirpes homoeopathicas et potentificandi.........................................................................7 Vaccinum influenzae inactivatum ex corticis antigeniis praeparatum ........................... 987 Vaccinum meningococcale classis C coniugatum ....................... 1004 Vaccinum pasteurellae inactivatum ad ovem......................................... 1011 Vaccinum rhinitidis atrophicantis ingravescentis suillae inactivatum... 983 Vaccinum rhinotracheitidis infectivae vivum ad meleagrem.............................................................................................. 949 Vaccinum paramyxoviris 3 aviarii inactivatum ad meleagrem................................... 997 Vaccinum rabiei ex cellulis ad usum humanum .......... 999 Vaccinum pertussis ex cellulis integris adsorbatum.... 1113 Xylazini hydrochloridum ad usum veterinarium ......................... 1416 Valinum.......................................................... 1005 Vaccinum rhinotracheitidis infectivae bovinae vivum ............ 3535 Vincristini sulfas........................................................................................................................................ 8........................................... 1007 Vaccinum morbillorum............................ 2966 Vaselinum flavum ............................................................................1–3697 Vaccinum mannheimiae bovinae inactivatum ......................... 8................................................................................................................ 950 Vaccinum parvovirosis caninae vivum ....................... 913 Vaccinum variolae gallinaceae vivum ... 3524 Vancomycini hydrochloridum...........3–4434 Xylometazolini hydrochloridum ................................................................................................. 3539 Vinpocetinum ................................................................ 947 Vaccinum morbi Carrei vivum ad mustelidas ...2–4109 Valerianae extractum aquosum siccum ....................................................................... 1325 Verbenae citriodorae folium ....................................................... 3547 Voriconazolum ........................................................... 882 Vaccinum pertussis sine cellulis ex elementis praeparatum adsorbatum........................... 907 Vaccinum tetani ad usum veterinarium ..........3–4433 Xylitolum ........................................... 859 Vaccinum parainfluenzae viri canini vivum ............ 995 Vaccinum pseudopestis aviariae vivum ............................................. 991 Vaccinum panleucopeniae felinae infectivae inactivatum ...............................................................2–3952 Vaccinum rabiei inactivatum ad usum veterinarium .......................................... 8........................................................................... 8............................................ 3545 Vitaminum A syntheticum..................................................................................................................................................5–4958 Valerianae tinctura ....................................................................................................................................... rubellae et varicellae vivum.................... 8....................................... 8............... 863 Vaccinum influenzae inactivatum ex corticis antigeniis praeparatum virosomale .................................................... 940 Vaccinum yersiniosidis inactivatum ad salmonidas...... 1420 Vitamini synthetici densati A pulvis ............................................ 981 Vaccinum variolae vivum................................................. 1022 Vaccinum rhinotracheitidis viralis felinae inactivatum .............................. 3529 Venlafaxini hydrochloridum.................................................. 923 Vaccinum morbi Carrei vivum ad canem.... 3536 Vindesini sulfas........................................................................................................ 1023 Vaccinum vibriosidis inactivatum ad salmonidas .................... 8......................... 898 Vaccinum rubellae vivum......................... 3528 Vedaprofenum ad usum veterinarium..... 872 Vaccinum morbillorum.............................................................................. 902 Vaginalia ... 1025 Vaccinum zonae vivum ............1–3830 X Xanthani gummi .. 986 Vaccinum mannheimiae inactivatum ad ovem ................ 900 Vaccinum Salmonellae Enteritidis inactivatum ad pullum ....... 8. 8.................... 8..5–4927 Vaccinum laryngotracheitidis infectivae aviariae vivum ..... 921 Vaccinum morbi Aujeszkyi vivum ad suem ad usum parenteralem......................... 1015 Vaccinum Salmonellae Typhimurium vivum perorale ad pullum .................................................2–4111 Vaselinum album ................................................ 873 Vaccinum morbillorum vivum........................ 889 Vaccinum poliomyelitidis perorale .............................................................................. 948 Vaccinum leucosis felinae inactivatum .............................................................................................................................. 3530 Verapamili hydrochloridum............................... parotitidis......................................3–4233 Vaccinum tuberculosis (BCG) cryodesiccatum............. 874 Vaccinum morbi Marek vivum ...................... 3537 Vinorelbini tartras................................................... 951 Vaccinum parvovirosis inactivatum ad suem .................................... 974 Vaccinum papillomaviri humani (ADNr) ...................................................... 963 Vaccinum pestis classicae suillae vivum ex cellulis .................... 990 Vaccinum myxomatosidis vivum ad cuniculum ...................................................................................................5–4957 Valerianae radix minutata.................................. 812 Valacicloviri hydrochloridum anhydricum ........................ 3534 Vinblastini sulfas ................. 8.........................................................1–3693 Vaccinum parotitidis vivum............................ 937 Vaccinum leptospirosis caninae inactivatum ............. 3546 Vitaminum A............................. 973 Vaccinum panleucopeniae felinae infectivae vivum ............................................................ 977 Vaccinum rotaviri vivum perorale ...... 861 Vaccinum influenzae vivum pernasale ........ 1412 Valerianae extractum hydroalcoholicum siccum ...................................... .................... 8............. 3585 Zinci sulfas heptahydricus .............................................................................................2–4115 Ziprasidoni hydrochloridum monohydricum....................................................................................................................................................... 3598 Zinci chloridum ......................... 3592 Zopiclonum........................................ 3595 Z Zinci undecylenas........................................... 8.............................................. 3595 Zinci sulfas hexahydricus ......... 1256 Zidovudinum .............................................................................7 Zinci stearas .......................................................7–5847 Zinci acexamas ..... 3601 Zinci oxidum ............................................................................................. 3593 Zuclopenthixoli decanoas .................... 3594 5904 See the information section on general monographs (cover pages) ........ 3591 Zolpidemi tartras ....................Index EUROPEAN PHARMACOPOEIA 8............................. 8.................................................................................................................................... 3590 Ziprasidoni mesilas trihydricus ................................... 3596 Zanamivirum hydricum.......... 3595 Zinci sulfas monohydricus.......................................................................................................................... 8.........4–4829 Zingiberis rhizoma ........... 3600 Zinci gluconas............................................................. 3594 Y Yohimbini hydrochloridum...3–4439 Zinci acetas dihydricus ......................
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