Third Generation Dissolution Testing: Dissolution as a Batch Phenomenon

Abstract

This paper provides an historical review of dissolution testing conducted by US Pharmacopeia, Inc. (USP). Current USP initiatives are also covered, including those designed to move USP to where it wants to be five and 10 years from now. There will be a lot happening with dissolution testing in the next few years. It is expected that as many as 80% of USP's 500-plus dissolution requirements will go to a lower total analytical test load mode.