Since the beginning of May 2023, the chapter "<2> Oral Drug Products - Product Quality Tests", which is part of the "General Tests & Assays" section, has been published on the website of the USP Pharmacopeial Forum for comments. Comments and remarks on this draft, which is based on the previous version from August 2020, can be submitted until 31 July 2023.
The revision of this chapter was initiated, for example, in order to reflect and incorporate the requirements of the "ICH Guideline Q6A-Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances". In addition to formal changes, the information regarding nitrosamine impurities and dissolution testing was adapted and the data from the FDA guideline for chewable tablets were incorporated.
The current draft consists of the following points:
The draft chapter "<2> Oral Drug Products - Product Quality Tests" can be viewed and commented on after a one-time registration on the Pharmacopeial Forum website.