The USP Performance Verification Test (PVT) assesses the suitable performance of apparatus used in dissolution testing. This assures reliability of dissolution results that reflects the quality of the drug product and not the condition of the test equipment. As such, the PVT in USP General Chapter <711> Dissolution is a core building block for dissolution instrument qualification.

The PVT appraises the suitable performance of the entire apparatus. By using standardized materials and procedures, your laboratory can compare results from your instrument with other laboratories worldwide. Results that do not meet the acceptance criteria can indicate the improper operation of the dissolution assembly, deviation from the procedure, or an error in conducting the test.

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.

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.