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Published on: August 11, 2017
Change in criteria for USP dissolution performance verification tests
Walter W Hauck1, Anthony J DeStefano, William E Brown
1US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852, USA. wh@usp.org
Abstract:
The US Pharmacopeial Convention has been evaluating its performance verification tests (PVT) for several years. These tests help ensure the integrity of the US Pharmacopeia performance test when a dissolution procedure, as described in General Chapter Dissolution <711>, is relied upon to test a nonsolution orally administered dosage form. One result of the evaluation is a change in the PVT criterion from one based on individual tablet results to one based on the mean and variability of a set of tablets. This paper describes the new PVT and its criterion and how its acceptance limits are derived from results of a collaborative study, explains a two-stage option for the test, and presents operating characteristics.
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