Performance Verification Test for Dissolution Apparatus (PVT)

A Performance Verification Test (PVT) is a comprehensive test outlined in the United States Pharmacopeia (USP) General Chapter <711>. It assesses the functionality of an entire dissolution apparatus setup, with a focus on demonstrating its suitability for use. The test employs Prednisone tablets as a reference standard. The primary objective of the PVT is to offer evidence of the instrument and apparatus being appropriate for their intended purpose.

The PVT evaluates various aspects, including measurable, dimensional, and operational parameters, which are crucial factors in determining the suitability of the dissolution apparatus. By conducting the PVT, it ensures that the entire dissolution system is functioning correctly and meets the necessary standards, thereby instilling confidence in its performance.

In recent developments, the USP has introduced a new 'Dissolution Performance Verification Standard' (DVPS) by reformulating Prednisone tablets. This change aims to enhance the reliability of performance qualification for both Dissolution Apparatus 1 (basket) and Dissolution Apparatus 2 (paddle). The new DVPS tablets feature a ball-shaped design, a departure from the previous convex tablet shape, and exhibit distinct behavioral characteristics.

The new formulation of Prednisone, represented by DVPS tablets, has been officially adopted as the standard for PVT as of May 1, 2023, coinciding with the revision of USP General Chapter <711> Dissolution. Extensive studies support the advantages of DVPS tablets, demonstrating their increased sensitivity to operational and mechanical variables within the instrument setup. Additionally, they are less sensitive to media degassing and yield more consistent results.

According to USP, the introduction of DVPS tablets is expected to provide greater accuracy, with a coefficient of variation (%CV) under 5% in both Dissolution Apparatus 1 and 2. These improvements contribute to a more reliable and precise performance verification process for dissolution apparatuses.