Nitrosamine risk assessment: a practical guide for API manufacturers
ICH M7 + regional supplements, with worked examples
A practical guide to running a nitrosamine risk assessment under ICH M7 and regional supplements. Covers assessment scope, analytical strategy (LC-MS/MS), acceptance limits, and how to file a mitigation plan when a signal is found.
- Structured risk assessment workflow per ICH M7
- Analytical method requirements — LC-MS/MS at 0.03 ppm
- Regional supplements: FDA, EMA, MHRA, PMDA
- Filing template for mitigation plans
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