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- Title
Change in Criteria for USP Dissolution Performance Verification Tests.
- Authors
Hauck, Walter; DeStefano, Anthony; Brown, William; Stippler, Erika; Abernethy, Darrell; Koch, William; Williams, Roger
- 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.
- Publication
AAPS PharmSciTech, 2009, Vol 10, Issue 1, p21
- ISSN
1530-9932
- Publication type
Article
- DOI
10.1208/s12249-008-9169-y