Performance qualification of the United States Pharmacopeia (USP) paddle apparatus (USP apparatus 2), as described in USP General Chapter <711> Dissolution, requires a demonstration of the dissolution behavior of a standard material as well as control of the mechanically measurable parameters of the apparatus. The USP performance verification test (PVT), an integral part of <711>, plays an important role in demonstrating the apparatus suitability and addressing the interlaboratory variability of dissolution results by using a standard procedure and reference standard material. The USP has used a specially formulated tablet containing prednisone in the role of the reference standard material that has been shown to be sensitive without undue variability. This paper describes how the use of the PVT ensures the accuracy of dissolution results by understanding and controlling the variability. This paper provides an overview of the following: the dissolution test; the mechanics of the test and associated hydrodynamics; the PVT reference standard; PVT and mechanical qualification.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2025 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.