title: Change in criteria for USP dissolution performance verification tests.
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.
authors.affiliation: US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852, USA. wh@usp.org
authors.forename: Walter W
authors.initials: WW
authors.lastname: Hauck
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: DeStefano
authors.forename: William E
authors.initials: WE
authors.lastname: Brown
authors.forename: Erika S
authors.initials: ES
authors.lastname: Stippler
authors.forename: Darrell R
authors.initials: DR
authors.lastname: Abernethy
authors.forename: William F
authors.initials: WF
authors.lastname: Koch
authors.forename: Roger L
authors.initials: RL
authors.lastname: Williams
mesh_terms: D000284:Administration, Oral; D017408:Guidelines as Topic; D008956:Models, Chemical; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012995:Solubility; D013607:Tablets / Q000592:standards*; D013678:Technology, Pharmaceutical / Q000592:standards*; D014481:United States
chemical_list: D013607:Tablets