Assay of active ingredients Weigh 20 tablets, grind, take weight of powder equal to one tablet. Analyze by the method prescribed in monograph Results obtained are expressed as %age of active ingredient as in single unit Compare with the standard Should be within specified limits usually ±10%
Contents of uniformity Based on assay of individual contents of active ingredient Determine individual contents of active ingredient of 10 units taken at random Test A (Tablets, Powder for parenteral use) Complies if contents lie between 85 -115% of the average label claim
Fails if more than one is out of this limit or one is outside 75-125% limit If one is out of 85-115% but within 75-125% , repeat the procedure with 20 more samples Complies if not more than 1 is out of 15% but all in 25%
Test B (capsules, powders, granules,suppositories) Complies if not more than one is out of 85-115% and all in 75-125% Fails if more than 3 individual contents are outside the limit of 85-115%, or if one or more contents are outside the limit of 75-125% If 2 or 3 are outside 85-115% but within 75-125% determine the contents of 20 more samples Complies if not more than 3/30 are outside 85-115% but all lies in 75-125%.
Test C Transdermal patches Average contents of 10 units should be between 90-110 % of the label claim and if each unit is between 75-125%
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