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Nitrosamine and Genotoxic Impurity Assessment
Assessment, development, validation and analysis to stringent LOQ requirements.
We help assess product-specific requirements and develop and validate methods for genotoxic impurities, achieving stringent LOQ requirements.
Our process covers complete assessment, development, validation and analysis of genotoxic impurities, assessed against the maximum daily exposure. We also assess new nitrosamine impurities identified by regulatory bodies, keeping pace with the latest standards and technology in N-nitrosamine analysis.
Our process
- Assessment of product-specific requirements
- Method development
- Validation to stringent LOQ
- Batch analysis against maximum daily exposure
- Assessment of newly identified nitrosamines