The U.S. Pharmacopeial Convention (USP) announces the release of a re-evaluated lot of Prednisone Reference Standard (RS) tablets. USP has, through a collaborative study, established new acceptance criteria for this material. The USP Performance Verification test using Prednisone RS tablets is used to periodically assess the overall performance of the dissolution test by the analyst. In addition to the re-issued lot and corresponding revised calculations, USP will be providing a free Web-based tool to aid manufacturers in calculations necessary to evaluate their test results. This validated compendial tool will be available at no charge by March 1, 2010.
USP establishes standards for the quality, purity, strength and identity of medications, as well as related standards for the testing of lab equipment, that are enforced by the Food and Drug Administration.
For more information on the new Prednisone RS tablets and the Web-based calculator, visit www.usp.org/goto/pvt or contact [email protected].