Revisions to the USP General Chapter <711> Dissolution are now official and the new standard for Performance Verification Testing is the only official standard as of May 1, 2023!
In our continued effort toward comprehensive qualification of dissolution instruments, we have developed a new product, Dissolution Performance Verification Standard (DPVS) – Prednisone tablets to create greater reassurance in the performance qualification of Dissolution Apparatus 1 and Dissolution Apparatus 2 using Performance Verification Testing.
Based on the studies that have been performed, the new product is more sensitive to operational and mechanical variables of instrument setup, less sensitive to media degassing, and delivers more consistent results.
Watch our short Q&A video with USP’s dissolution expert Mark Liddell.
For more updates on the new product, please provide the following information:
Contact Us: Questions about the current or new product? Contact RSTech@usp.org
Questions about <711> or NITR? Contact Margareth Marques, firstname.lastname@example.org
Copyright © 2020, All rights reserved.
Our mailing address is: The United States Pharmacopeial Convention Inc 12601 Twinbrook Parkway Rockville, MD 20852-1790
Importance of PVT Testing
The USP Performance Verification Test (PVT) is an integral part of the General Chapter <711> Dissolution and assesses proper dissolution apparatus performance. PVT is a holistic test and by using the reference standard material and the standard procedure, laboratories can compare results from their instrument with other laboratories worldwide. The PVT acceptance criteria for geometric mean (GM) and coefficient of variation (%CV) are a measure for the accuracy and precision of the results within the context of ISO 5725-6.