Change in Criteria for USP Dissolution Performance Verification Tests |
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Authors: | Walter W Hauck Anthony J DeStefano William E Brown Erika S Stippler Darrell R Abernethy William F Koch Roger L Williams |
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Institution: | (1) US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland 20852, USA |
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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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Keywords: | acceptance criteria data analysis dissolution test performance verification test reference standards |
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