QUALITY CONTROL TESTSFOR TABLETS AND CAPSULES Quality Control of Tablets General Appearance: -Size, shape, and thickness: This is important to facilitate packaging and to decide which tablet compressing machine to use. -Organoleptic properties: which include color and odor of the tablets. P.S.P./ U. COMPARISON OF DIFFERENT PHARMACOPOEIAL QUALITY CONTROL TESTS BRITISH PHARMACOPOEIA FOR ALL TABLETS: Content of active ingredients Disintegration Uniformity of content Labeling . /I.P.Official Standards as per B. Uncoated tablet: -Disintegration test -Uniformity of weight Effervescent tablet: -Disintegration test -Uniformity of weight Coated tablet: -Disintegration test -Uniformity of weight . Gastro resistant tablet: -Disintegration test Modified release tablet: -Uniformity of weight. Dispersible tablet: -Disintegration test -Uniformity of dispersion -Uniformity of weight . INDIAN PHARMACOPOEIA Uncoated tablet: -Uniformity of container content -Content of active ingredient -Uniformity of weight -Uniformity of content -Disintegration test Enteric coated tablet: -Disintegration test . Dispersible tablet: -Uniformity of dispersion -Disintegration Soluble tablet: -Disintegration test Effervescent tablet: -Disintegration/ Dissolution / Dispersion test . UNITED STATES PHARMACOPOEIA Physical tests applicable to tablet formulation: -Bulk density /Tapped density of powder -Powder fineness -Loss on drying -Disintegration test -Tablet friability -Dissolution test -Drug release testing -Uniformity of dosage form -Container permeation test -Labeling of inactive ingredients . disintegration. friability. drug content.Official and unofficial tests: Official Tests: Weight variation. Non-Official Tests: Hardness. . dissolution. Why do we measure hardness? To determine the need for pressure adjustments on the tableting machine. And if the tablet is too soft. Hardness can affect the disintegration.I. it will not withstand the handling during subsequent . it may not disintegrate in the required period of time.Non official tests: Hardness (crushing strength): It is the load required to crush the tablet when placed on its edge. So if the tablet is too hard. we accept the patch. And if the disintegration is within limit. >If H. we first check its disintegration before rejecting the patch. . is high + disintegration is within time è accept the batch. >In general.processing such as coating or packaging. if the tablet hardness is too high. Limits: 5 kilograms minimum and 8 kilograms maximum. Amount of binder. (More binder à more hardness) Method of granulation in preparing the tablet (wet method gives more hardness than direct method.Factors Affecting the Hardness: Compression of the tablet and compressive force. . Slugging method gives the best hardness). Friability: It is the tendency of tablets to powder. . or fragment and this can affect the elegance appearance. chip.>Make hardness test on 5 tablets and then take the average hardness. and also add to tablet’s weight variation or content uniformity problems. consumer acceptance of the tablet. Friability is a property that is related to the hardness of the tablet. . An instrument called friabilator is used to evaluate the ability of the tablet to withstand abrasion in packaging. handling. and shipping. Friability (% loss) = It must be less than or equal to1% but if more we do not reject the tablets as this test is non-official. Perform this test using 20 tablets that were used first in the weight variation test .Procedure: 1. = 25 rpm for 4 min) 3. Put these tablets in the friabilator and adjust the instrument at 100 rpm (i. Weigh 20 tab altogether = W1 2.e. Weigh the 20 tablets (only the intact ones) = W2 4. Official Tests: Disintegration: It is the time required for the tablet to break into particles. .II. the disintegration test is a measure only of the time required under a given set of conditions for a group of tablets to disintegrate into particles. KH2PO4 (phosphate buffer) + pencreatin enzyme +NaOH) .5. simulated gastric fluid (PH = 1. or Simulated intestinal fluid (PH = 7.2 HCl). Liquids used in disintegration Water. Limits: For Uncoated tablets: Medium Temper Time ature limit According to Simulated 37oC Not U.P. gastric exceed fluid 30min According to water 37oC Not B.P. exceed 15min .S. the batch must be rejected.P. Not less then 16 tablets disintegrate completely within the time if more then two tablets (from the 18) fail to disintegrate. the whole test will consume 18 tablets). method for uncoated tablets: Start the disintegration test on 6 tablets. . (i.S.e. If one or two tablets from the 6 tablets fail disintegrate completely within 30min repeat the same test on another 12 tablet.U. If not disintegrated. repeat on 12 tablets. >If one or two tablets fail to disintegrate.P).S. Put the tablet in the apparatus in water or HCL for 30min at 37oC (according to the U. put in intestinal fluid. . To remove or dissolve the coat.For Coated tablets: 1. So 16 tablets from the 18 must completely disintegrate within the time >>if two or more not disintegrated the batch is rejected. immerse the tablet in distilled water for 5min. Put in distilled water for five minutes to dissolve the coat. Then put in simulated intestinal fluid for two hours.U. repeat this test on another 12 tablets. Method for Enteric coated tablets: 1. So 16 tablets from 18 should completely disintegrate. . 3. If one or two tablets fail to disintegrate.P. 2. If more than two fail to disintegrate the patch must be rejected. Then put in simulated gastric fluid (0.S.1M HCL) for one hour. If one or two tablets fail to disintegrate repeat on 12 tablets.B. Put in phosphate buffer (PH 6. Put in simulated gastric fluid for two hours (emptying time). . method for Enteric coated tablets: 1. 4. Put in distilled water for five minutes to dissolve the coat. So 16 tablets should disintegrate. If more than two tables fail to disintegrate reject the batch. 3. 2.P.8) for one hour. X= (X1+X2 +X3+…+ Xz)/20 Limits according to U.Weight Variation (uniformity of weight) of tablets: 1. X2. Determine the average weight. X1.S. Weigh 20 tablet selected at random.P · Weight of tablet 130 mg or less then %error = ±10% · Weight of tablet 130-324 mg then %error = ±7. X3… Xz 2.5% · Weight of tablet 324 mg or more then %error = ±5% . each one individually . and no tablet differs by more than double that percentage. >>Not more than two of the tablets differ from the average weight by more than the % error listed. .Limit: Upper limit = average weight + (average weight * %error) Lower limit = average weight .(average weight * %error) The individual weights are compared with the upper and lower limits. Operate the apparatus for 30 minutes. method for disintegration of capsules: Introduce one capsule into each tube and suspend the apparatus in a beaker containing 600 ml water @ 37oC.P. the discs may be added.Quality control tests of capsules B. remove the assembly from the liquid. it consists of fragments of shell or. >The capsules pass the test if No residue remains on the screen of the apparatus or. If a residue remains. . If hard capsules float on the surface of the water. and none deviates by more than twice that percentage.Uniformity of Weight of capsules: It is to be done on 20 capsules. Limit: Not more than two of the individual weights deviate from the average weight by more than the percentage deviation shown in the table. . 5 .Average Weight of Capsule Percentage Deviation Less than 300 mg 10 300 mg or more 7.