Dissolution Performance Verification Testing (PVT)

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 trueness and precision of the results within the context of ISO 5725-6.

Resources

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  • Calculation Tool for PVT of Dissolution Assemblies: The PVT calculation tool calculates the geometric mean (GM) and coefficient of variation (%CV) using unrounded dissolution results (% dissolved of the label claim) and compares these values with the respective ranges given in the Certificate. A pass/fail message is displayed on the calculation sheet.
  • Dissolution Toolkit Version 2.0 (Procedures for Mechanical Calibration and Performance Verification Test  (Apparatus 1 and Apparatus 2) This document provides a detailed description of best practices gained by USP Laboratory for mechanical calibration and Performance Verification Test of USP basket and paddle dissolution apparatuses and test assemblies. Updated October 7, 2016) (en español)
  • FAQs: Reference Standards | Dissolution PVT

PVT Tablets: Current and Previous Lot Certificates and Data

Reference Standard Ranges for Dissolution Performance Verification included where appropriate.

USP Prednisone Tablets Reference Standards (Performance Verification Tablet, Disintegrating)