Change in criteria for USP dissolution performance verification tests.
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.
Hauck
Walter W
WW
US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852, USA. wh@usp.org
DeStefano
Anthony J
AJ
Brown
William E
WE
Stippler
Erika S
ES
Abernethy
Darrell R
DR
Koch
William F
WF
Williams
Roger L
RL
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
D013607:Tablets