01 mayo 2023

New Standard for Dissolution Performance Verification Test (PVT)

On 01 May 2023, the United States Pharmacopeia (USP) has introduced a new formulation of their prednisone tablets. Make sure to use this new 'Dissolution Performance Verification Standard' (DPVS) for your performance verification tests (PVT).

What is a Performance Verification Test (PVT)?

The Performance Verification Test (PVT) described in United States Pharmacopeia (USP) General Chapter <711>, is a holistic test that demonstrates the operation of the entire dissolution instrument setup. For this test, Prednisone tablets are used as a reference standard. The purpose of the PVT is to provide evidence of instrument and apparatus suitability. USP considers adherence to measurable, dimensional, and operational parameters to be a critical component of dissolution apparatus suitability. The PVT provides a test of the 'fitness for purpose' of the entire dissolution system and confidence that the instrument is functioning properly.

What's different with the new DVPS tablets?

In the strive of continuously improving, USP has changed the formulation of the Prednisone tablets and developed a new ‘Dissolution Performance Verification Standard’ (DVPS) to create greater reassurance in the performance qualification of Dissolution Apparatus 1 (basket) and Dissolution Apparatus 2 (paddle). The new ball-shaped DVPS tablets show a significant deviation from the previous convex tablet shape and have distinct behavioral characteristics. The new prednisone formulation is the official standard for PVT since 01 May 2023 when the revised USP General Chapter <711> Dissolution has become official. 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. According to USP you can expect greater accuracy with %CV under 5% in both apparatus 1 and 2 with the new DVPS Prednisone tablets.