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.
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Booth #1123 – Nov. 12-15, 2017
Calculation Tool for the 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.
Procedures for Mechanical Calibration and
PVT (Apparatus 1 and Apparatus 2)
This document provides a detailed description
of best practices gained by USP Laboratory
for mechanical calibration and PVT of USP
basket and paddle dissolution apparatuses
and test assemblies.