Unit Operations

USP Re-evaluates Dissolution Test Tablets, Methods

Source: PharmaManufacturing.com

Apr 06, 2010

USP has re-evaluated the currently available Prednisone RS Tablets Lot P0E203 and established new acceptance criteria based on a whole-assembly geometric mean and standard deviation approach rather than the individual-position (per tablet) approach.

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. A certificate, and an online tool, are on www.usp.org to help with calculating acceptance criteria.