Genotoxic impurities
Mérieux NutriSciences’long-standing experience in residual analysis – our in-house residual methods are published in international specialized scientific journals – and collaboration with Pharmaceutical Companies for genotoxic impurities determination, have allowed us to have the necessary skills to apply a different approach depending on the problem to be solved:
- Search for in-house/official suitable methods already available
- Method development by means of high sensitive and state-of-the-art technologies
- Method validation in full compliance with ICH Q3A/B and ICH Q2 guidelines
About the team
- Dedicated R&D team for method development
- Dedicated GMP lab for method validation and QC
Analytical techniques
- LC-MS/MS (APCI/ESI)
- LC-HRMS
- GC‐MS
- GC-MS/MS
Genotoxicity safety tests
Identification of nitrosamine impurities (NI)