Research Paper

Pharmaceutical Research

, Volume 25, Issue 5, pp 1110-1115

First online:

The USP Performance Verification Test, Part II: Collaborative Study of USP’s Lot P Prednisone Tablets

  • Maria GlasgowAffiliated withUnited States Pharmacopeia
  • , Shawn DressmanAffiliated withUnited States Pharmacopeia
  • , William BrownAffiliated withUnited States Pharmacopeia
  • , Thomas FosterAffiliated withUSP 2005–2010 Biopharmaceutics Expert Committee, University of Kentucky Medical Center College of Pharmacy
  • , Stefan SchuberAffiliated withUnited States Pharmacopeia
  • , Ronald G. ManningAffiliated withDepartment of Health and Human Services
  • , Samir Z. WahabAffiliated withUnited States Pharmacopeia
  • , Roger L. WilliamsAffiliated withUnited States Pharmacopeia Email author 
  • , Walter W. HauckAffiliated withUnited States Pharmacopeia

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Abstract

Purpose

Periodic performance verification testing (PVT) is used by laboratories to assess and demonstrate proficiency and for other purposes as well. For dissolution, the PVT is specified in the US Pharmacopeia General Chapter Dissolution <711> under the title Apparatus Suitability Test. For Apparatus 1 and 2, USP provides two reference standard tablets for this purpose. For each new lot of these reference standards, USP conducts a collaborative study.

Methods

For new USP Lot P Prednisone Tablets, 28 collaborating laboratories provided data. The study was conducted with three sets of tablets: Lot O open label, Lot O blinded, and Lot P blinded. The blinded Lot O data were used for apparatus suitability testing.

Results

Acceptance limits were determined after dropping data due to failure of apparatus suitability, identification of data as unusual on control charts, or protocol violations.

Conclusions

Results yielded acceptance criteria of (47, 82) for Apparatus 1 and (37, 70) for Apparatus 2. Results generally were similar for Lot P compared to results from Lot O except that the average percent dissolved for Lot P is greater than for Lot O with Apparatus 2.

Key words

acceptance limits disintegration dissolution Performance Verification Test United States Pharmacopeia