USP: Stimuli Article on Mutagenic Impurities published for Comments

Recommendation
14/15 October 2025
With updates on the CEP 2.0!
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.
Related GMP News
08.10.2025US FDA Warning Letter: Inadequate Investigation of Complaints
08.10.2025Data Integrity and the ICH Q7 Guidance - Part I
03.09.2025USP: Chapters 'Balances <41>' and 'Weighing on an Analytical Balance <1251>' final
27.08.2025ECHA: 'PFAS' Restrictions updated
20.08.2025EMA/HMA: Nitrosamine Report published
13.08.2025IPEC: Risk Assessment Guide for Excipients now available