USP: Chapter "<2> Oral Drug Products - Product Quality Tests" published for Comments

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:

  • Introduction 
  • Drug Product Quality Tests and Performance Tests 
  • Performance Tests for Oral Drug Products 
  • Quality Tests for Oral Drug Products 
  • Universal Tests for Oral Drug Products 
  • Specific Tests for Tablets 
  • Specific Tests for Uncoated Tablets 
  • Specific Tests for Coated Tablets 
  • Specific Tests for Capsules 
  • Specific Tests for Granules 
  • Specific Tests for Powders 
  • Specific Tests for Liquids 
  • Specific Tests for Miscellaneous Oral Dosage Forms

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.

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