Evaluation of U. S. Pharmacopeia Sampling Plans for Dissolution

Abstract

The United States Pharmacopeia presents sampling plans and specifications for pharmaceutical products which are used in judging the quality of these products. Previously accepted and revised sampling plans for product dissolution are evaluated and compared using conventional statistical techniques and computer simulation. This paper presents operating characteristic curves and related graphs for these dissolution sampling plans that form a basis upon which lots of dosage units are accepted or rejected. These plans have also been evaluated for their effectiveness in assuring the quality of drug products.

• Dissolution Testing
• USP Sampling Requirements
• Monte Carlo Simulation
• Operating Characteristic Curve

Additional information

Notes on contributors

Charles B. Pheatt

Mr. Pheatt is a senior statistician in the Scientific Evaluation Department and a member of ASQC.