The % rsds for drug content and weight meet the usp specification. The text presented herein represents a merger of the stage 5b text and the national usp text. In the case of a twocomponent tablet, the uniformity of dosage units test requirement will be met by the weight variation procedure for the component that is present at 25 mg or more and also comprising 25% of the total dosage unit mass. Uniformity of dosage units bp 2011, usp 34 massweight variation mvwv assay for the drug substances on a representative. Uniformity of dosage units, usp 27 page 2396 and page 1587 of. When the test for content uniformity is not required, the test for weight variation may be applied. Criteria sections for content uniformity and weight variation test sections. If the acceptance value is greater than l1%, test the next 20 units. Weight variation of tablets conform to the criteria given in the accompanying dietary supplements table. The acceptance value of the first 10 dosage units is less than or equal to l1%.
Uniformity of dosage units european medicines agency. Mass weight variation test as an alternative test for content uniformity is not. Summary of usp applies to many dosage forms weight variation wv versus content uniformity cu for tablets as an example if 25 mg and 25%. The first paragraph in the weight variation section of the current text contains new text for clarity. Usp guidelines for weighing in pharmaceutical industry. The goal of this study was to investigate the physical quality control parameters of dietary supplements tablets commercially available on the kingdom of saudi arabia by using weight variation. The other component will require the content uniformity procedure. Pdf weight and content uniformity of warfarin sodium half tablets. Qualitycontrol analytical methods homogeneity of dosing forms. Uspnf general chapter uniformity of dosage units uspnf. January 1, 2007, to allow usp to consider comments received on weight. Topical and transdermal drug products the topicaltransdermal ad hoc advisory panel for the usp performance tests of topical and transdermal dosage forms. Uncoated tablets and filmcoated tablets the following tests provide limits for the permissible variaweigh individually 20 whole tablets, and calculate the avtions in the weights of individual tablets or capsules, ex erage weight. Warfarin sodium, tablets, weight variation, drug content.
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