Register Agenda & USP participation - Coming soon!
As USP begins developing new compendial tools based on the ICH M7(R2) guideline, we welcome stakeholders and subject matter experts to an April 30 virtual workshop to share perspectives on USP’s approach to controlling mutagenic impurities in medicines. The workshop will provide an opportunity for participants from industry, academia, and regulatory bodies to offer input on the development and use of compendial standards in this area.
Your expertise and perspective will help shape this important initiative. For questions or to express interest in participating, contact micf@usp.org.
Registered attendees will receive additional updates before the meeting, including agendas and other pre-reads.
How to Participate
If you have questions or would like to express interest in contributing directly, please contact: micf@usp.org
Background Resources
General Announcement Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF; Developing the Mutagenic Impurity Compendial Framework
A foundational announcement introducing USP’s approach to building a compendial framework for assessing and managing mutagenic and potentially mutagenic impurities in the United States Pharmacopeia–National Formulary (USP–NF).
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Issue Brief A compendial framework for mutagenic impurities in medicines
A concise overview outlining the public health rationale, proposed frameworks, regulatory alignment, and USP scientific perspectives on managing mutagenic impurities throughout the product lifecycle.
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USP Mutagenic Impurities Hub
Central resource page with detailed scientific materials, background information, related standards, FAQs (coming soon), and ongoing USP initiatives related to mutagenic and potentially mutagenic impurities.
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We look forward to your active involvement in shaping the future of compendial tools for mutagenic impurities!