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level: Level 2

Questions and Answers List

level questions: Level 2

QuestionAnswer
It is a test for the uniformity of the weight of the tablets Performed by weighing 20 tablets randomly selected from a batch and determining their average weight.Weight Variation Test
Weight Variation Test Limits according to USP1 Weight of tablet 130 mg or less then %error = ±10% 2 Weight of tablet 130-324 mg then %error = ±7.5% 3 Weight of tablet 324 mg or more then %error = ±5%
Weight Variation Test, tablets pass USP test if: __1 No more than 2 indiv tablets are outside the percentage limit 2 No tablet differs by more than 2x the percentage limit
Every tablet contains the amount of drug substances intended with LITTLE VARIATION among tablets WITHIN A BATCHContent Uniformity
1 For content uniformity test, representative sample of __ are selected and __ are assayed individually. 2 Nine of the 10 tablets must contain __ 3 If one or more dosage units do not meet the criteria, the remaining __ tablets are assayed individually and none may fall outside __ range for the batch to be accepted1) 30 tablets, 10 2 Not less than 85% or more than 115% of the labeled drug content 3) 20 tablets, Not less than 85% or more than 115% range
For a drug to be absorbed from a solid dosage form from oral administration, it must first be in solution, and the first step is the break up of the tablet, a process known as __Disintegration
Tablet disintegration provides drug particles with an INCREASED __Surface Area
A measure of time required under a set of conditions for a group of tablets to disintegrate into particles which will pass through a 10 mesh screenDisintegration Test
Liquids used in Disintegration1 Water 2 Simulated gastric fluid (pH= 1.2 HCl) 3 Simulated Intestinal fluid (pH= 7.5, Phosphate buffer, +pancreatin enzyme + NaOH)
USP FOR UNCOATED TABLETS1) Disintegrate test for 6 TABLETS 2) if 1 or 2 fail to disintegrate within 30 mins, repeat the test for another 12 TABLETS 3 NOT LESS THAN 16 TABLETS must disintegrate completely 4 if MORE THAN 2 TABLETS FAIL to disintegrate, BATCH REJECTED
USP FOR COATED TABLETS1 put tablet in distilled water for 5 mins (Remove coat) 2 Put tablet in WATER or HCL for 30 mins at 37C 3 if NOT DISINTEGRATE, put in INTESTINAL FLUID 4 If 1 or 2 fail to disintegrate, repeat on 12 TABETS 5) NLT 16 TABLETS from 18 must disintegrate, if 2 OR MORE did not, BATCH REJECTED
USP FOR ENTERIC COATED TABLETS1 Put tablet in distilled water for 5MINS (remove coat) 2 PUT Gastric Fluid (0.1M HCl) for 1 HOUR 3 Then PUT Intestinal Fluid for 2 HOURS 4 IF 1 or 2 TABLETS FAIL, Repeat for another 12 16 tablets should disintegrate, if TWO OR MORE FAILS, BATCH REJECTED
B.P. Method for Enteric Coated Tablets1 Put tablet in distilled water for 5MINS (remove coat) 2 PUT Gastric Fluid (0.1M HCl) for 2 HOURS 3 Then PUT Phosphate Buffer for 1 HOUR 4 IF 1 or 2 TABLETS FAIL, Repeat for another 12 16 tablets should disintegrate, if TWO OR MORE FAILS, BATCH REJECTED