Dissolution Performance Verification Testing (PVT)

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This page provides updated information and links related to Dissolution Performance Verification Testing (PVT). For your convenience, current and past USP specification standards are posted.

Updates and Relevant Links

Pharmacopeial Education Course: Dissolution: Theory and Best Practices
Updated FAQs for Prednisone Tablets (posted August 24, 2010)
Notice to Purchasers of USP Prednisone Tablets Lot P1I300 Concerning Relabeling (188KB) (posted June 1, 2010)
USP Certificate for Prednisone Tablets Lot P1I300 corrected (79KB) (posted April 1, 2010)
Dissolution Toolkit Version 2.0 (280KB) (posted April 1, 2010)
Calculation Tool for the Performance Verification Test (PVT) of Dissolution Assemblies (posted February 22, 2009)
Performance of Equipment to Test Dissolution of Medications Further Assured (posted February 9, 2010)
Explanation Letter of Future and Current Lots of Prednisone Tablets (211KB) (posted January 20, 2010)
Stimuli Article PF 34–6 Description of the Upcoming Change in Data Analysis for USP Dissolution Performance Verification Tests (527KB)
Changes to the Dissolution Performance Verification Test (101KB) (posted November 20, 2009; official December 1, 2009)

Specifications for PVT Tablets

(Reference Standard Ranges for Dissolution Performance Verification included where appropriate)

USP Prednisone Tablets Reference Standards (Performance Verification Tablet, Disintegrating)
- Lot P1I300 (128KB)
- Update Lot P0E203 (123KB) (effective July 16, 2007)
- Lot P0E203 (66KB)
- Update Lot O0C056 (1.2MB) (effective December 6, 2004)
- Lot O0C056 (237KB)
- Lot N (159KB)
USP Chlorpheniramine Maleate Extended–Release Tablets (Drug Release Calibrator, Single Unit)
- Update Lot G0B259 (44KB) (effective September 30, 2004)
- Lot G0B259 (144KB)
USP Salicylic Acid Tablets Reference Standards (Dissolution Calibrator, Nondisintegrating). As of December 1, 2009 not a Compendial Requirement.