Weight variation usp pdf

Usp guidelines for weighing in pharmaceutical industry. The national text procedures and criteria for suppositories. Where the weight variation test is used in this way, the product must, if tested, nevertheless comply with the official compendial test for content uniformity. Inprocess and finished products quality control tests for pharmaceutical tablets according to pharmacopoeias. Topical and transdermal drug products the topicaltransdermal ad hoc advisory panel for the usp performance tests of topical and transdermal dosage forms. 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, usp 27 page 2396 and page 1587 of. The united states pharmacopeia usp general chapters balances and weighing on an analytical balance aim to ensure weighing accuracy and eliminate unnecessary overtesting for us pharmaceutical manufacturers and suppliers. Pdf inprocess and finished products quality control. Warfarin sodium, tablets, weight variation, drug content. Uniformity of dosage units bp 2011, usp 34 massweight variation mvwv assay for the drug substances on a representative. If the acceptance value is greater than l1%, test the next 20 units. 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 other component will require the content uniformity procedure. Uniformity of dosage the test for content uniformity is required for all dosage forms not meeting the above conditions for the weight variation test. Qualitycontrol analytical methods homogeneity of dosing forms. The acceptance value of the first 10 dosage units is less than or equal to l1%.

January 1, 2007, to allow usp to consider comments received on weight. Pdf weight and content uniformity of warfarin sodium half tablets. 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 first paragraph in the weight variation section of the current text contains new text for clarity. The % rsds for drug content and weight meet the usp specification.

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. The text presented herein represents a merger of the stage 5b text and the national usp text. When the test for content uniformity is not required, the test for weight variation may be applied. Weight variation of tablets conform to the criteria given in the accompanying dietary supplements table. Uniformity of dosage units european medicines agency. Content uniformity cu testing for the 21st century. Mass weight variation test as an alternative test for content uniformity is not. Uspnf general chapter uniformity of dosage units uspnf. The test for weight variation is applicable for the following dosage forms. The requirements are met if the final acceptance value of the 30 dosage units is less than or equal to l1% and all individual dosage units fall within the range calculated using l2 factor.