Performance of Equipment to Test Dissolution of Medications Further Assured

February 9, 2010

USP Performance Verification Test (PVT) – New Approach

Over the last several years, USP has strengthened its approaches to assure the integrity of the USP Performance test, as described in General Chapter Dissolution <711> and referenced in official text in the United States Pharmacopeia (USP) for orally administered drug products. These approaches have included a) reference to a periodic performance verification test (PVT) in General Chapter Dissolution <711>; b) a Toolkit that describes how to conduct both mechanical calibration of the dissolution apparatus as well as the PVT that is used periodically to assess overall performance of the test by the analyst; c) improved statistical analyses of the results of a PVT (1–2), and d) elimination of the requirement for a dual PVT with both the USP Salicylic Acid Reference (RS) Tablets and Prednisone RS Tablets, relying instead only on the latter for a single PVT.

PVT Reference Standard

Continuing the overall effort to strengthen approaches to assure the integrity of the USP Performance test, USP has re–evaluated the currently available Prednisone RS Tablets Lot P0E203 via a new collaborative study and has established new acceptance criteria from this study based on a whole–assembly geometric mean and standard deviation approach rather than the individual–position (per tablet) approach. (2).

The re–evaluated material, Prednisone RS Tablets Lot P1I300, will be available for use in the PVT as a continuation lot of Lot P0E203, replacing the current Lot P0E203 as of April 30, 2010. Lot P1I300 will be available on or about March 1, 2010. On April 30, 2010, Lot P0E203 will no longer be official. Customers purchasing Lot P0E203 are advised to order minimal quantities. Information about the calculation of the acceptance criteria for Lot P1I300 will be provided on a certificate that accompanies the newly issued Prednisone RS Tablets Lot P1I300 in March, 2010.

PVT Calculation Tool

To further assist manufacturers and others wishing to assure the integrity of the USP Performance test, USP will provide a validated, web–based tool for use in conducting the calculations necessary to evaluate the results of a PVT. Users can enter data from a PVT, and the tool will calculate results automatically. USP offers the Web–based tool as a convenient option and not as a requirement. All equations used in the Web tool are included in the USP certificate. This tool will be available at no charge by March 1, 2010 on USP’s website.

1. Hauck WW, DeStefano AJ, Brown WE, Stippler ES, Abernethy DR, Koch WF, Williams RL. Change in Criteria for USP Dissolution Performance Verification Tests. AAPS PharmSciTech 10:21–6;2009.

2. Stimuli to the Revision Process article: Description of the Upcoming Change in Data Analysis for USP Dissolution Performance Verification Tests, WW Hauck, et al., Pharmacopeial Forum 34(6) [Nov–Dec 2008]).