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This FAQs section details frequently asked questions about the ICH M7 guidelines. For FAQs on Lhasa products, please refer to the relevant product area.
Why do I need to run in silico for impurities or degradants?
The draft ICH M7 guidelines on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk, state that actual and potential impurities should be assessed for their mutagenic potential. The guidelines state that (Q)SAR methodologies can be used as part of this hazard assessment.
Potential impurities could include:
- Starting materials and their contaminants
- Reagents and catalysts
- Excipients and their contaminants
- Degradation products