USP: Stimuli Article on Mutagenic Impurities published for Comments

Recommendation

22/23 February 2024
Munich, Germany

API Regulatory Starting Materials
Definition, Manufacture, Assessment and handling post-approval Changes

Since the beginning of September 2022, the stimuli document "Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF" has been published for comments on the website of the Pharmacopeial Forum of the USP. Comments and observations on this draft can be submitted until 30 November 2022.

This draft is divided into the following chapters and subchapters:

• Introduction
  - USP Options - Alternative Scenarios under Assessment
  - Proposed approaches to introduce mutagenic impurity concepts generally into the compendium
  - Proposed approaches to address mutagenic impurities at the level of the monograph
  - Proposed approaches to alert users to the possible presence of mutagenic impurities, either within or outside of the compendial requirements (through additional information) 
• Request to stakeholders 
• References

To get to the stimuli document "Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF" and to comment on it you need to first register on the Pharmacopeial Forum website.