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Cosmetic Pharma
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Nitrosamines Risk Management (CPCA & Acceptable Intake)
A comprehensive service to manage the risk of nitrosamine presence in medicinal products — combining scientific advisory, CPCA categorisation and the Enhanced Ames Test for Acceptable Intake determination.
What's inside
- 2023+ regulatory landscape for nitrosamines and NDSRIs
- Carcinogenicity Potency Categorisation Approach (CPCA)
- Acceptable Intake (AI) determination from structure
- Combined scientific advisory + Enhanced Ames Test service
Major regulatory updates issued from 2023 onward have reshaped how the mutagenic and carcinogenic potential of NDSRIs is predicted, and how Acceptable Intakes (AIs) are determined. The Carcinogenicity Potency Score is calculated from the chemical structure of the NDSRI compound.
GenEvolutioN has developed a comprehensive service offering for managing the risk of nitrosamine presence in medicinal products, combining the Enhanced Ames Test (EAT), the Carcinogenicity Potency Categorisation Approach (CPCA) and a methodology for AI determination based on the structural features of NDSRIs, supported by scientific advisory.
Who this is for
- Pharmaceutical regulatory and quality teams
- Nitrosamine risk owners and CMC leads
- Marketing authorisation holders managing impurity risk
Recommended citation
GenEvolutioN Scientific Team (2025). Nitrosamines Risk Management (CPCA & Acceptable Intake). GenEvolutioN Technologies.