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Enhanced Ames Test for Nitrosamine Impurities (NDSRIs)
Nitrosamines are probable human carcinogens requiring metabolic activation. The Enhanced Ames Test meets US-FDA and EMA recommendations for detecting the mutagenic potency of NDSRIs.
What's inside
- Why nitrosamines and NDSRIs are a regulatory priority
- Reduced sensitivity of the standard Ames assay for some N-nitrosamines
- Enhanced Ames Test (EAT) conditions per US-FDA and EMA
- Application to Nitrosamine Drug Substance Related Impurities (NDSRIs)
Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies, and require metabolic activation to show mutagenic potency.
For N-nitrosamines, enhanced testing conditions for the Ames assay are recommended by the US-FDA and EMA due to the reported reduced sensitivity of the standard assay for some compounds, such as N-nitroso-dimethylamine (NDMA). Very little is known about the sensitivity of the Ames assay to Nitrosamine Drug Substance Related Impurities (NDSRIs) — the Enhanced Ames Test (EAT) addresses this gap with optimised, regulator-aligned conditions.
Who this is for
- Pharmaceutical genotoxicity and impurity teams
- Regulatory affairs managing nitrosamine risk
- CMC and quality professionals
Recommended citation
GenEvolutioN Scientific Team (2025). Enhanced Ames Test for Nitrosamine Impurities (NDSRIs). GenEvolutioN Technologies.