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Nitrosamines: Comprehensive Risk Management Framework
A structured three-step nitrosamine risk framework — evaluation, analysis and control — spanning hazard identification, predicted and confirmatory testing, and mitigation.
What's inside
- Step 1 — Risk evaluation & hazard identification
- Step 2 — Risk analysis: predicted levels, AI estimation (QSAR/CPCA)
- Step 3 — Confirmatory testing (EAT, HPRT/MLA, micronucleus)
- Bioactivation studies and documented control strategy
GenEvolutioN’s comprehensive nitrosamine risk management framework organises the work into three steps.
Step 1 — Risk evaluation: theoretical hazard identification, documentation review of the risk of nitrosamine and precursor presence, and prediction of N-nitroso compound formation pathways.
Step 2 — Risk analysis: real and predicted level assessment, synthesis and qualification of nitroso-impurities, and estimation of the Acceptable Intake (QSAR / CPCA).
Step 3 — Risk control: confirmation of the Acceptable Intake via the Enhanced Ames Test (EAT), mammalian cell assays (HPRT/MLA) or the micronucleus test, bioactivation studies and a documented control strategy.
Who this is for
- Pharmaceutical regulatory, quality and CMC teams
- Nitrosamine risk owners
- Marketing authorisation holders
Recommended citation
GenEvolutioN Scientific Team (2025). Nitrosamines: Comprehensive Risk Management Framework. GenEvolutioN Technologies.