Aug 19, 2025
Nitrosamine drug substance-related impurities (NDSRIs) are a class of nitrosamine impurities observed in APIs and drug products. Recent regulatory guidance warrants the evaluation of carcinogenicity risk from nitrosamines. It is necessary to investigate the potential for metabolic activation of NDSRIs and the stability/reactivity of the resulting metabolites. We offer the following nitrosamine metabolism studies in human liver microsomes and hepatocytes - ▶️ Metabolic stability ▶️ Metabolite identification ▶️ Reactive metabolite trapping using glutathione Uncover nitrosamine risks before they become regulatory hurdles – Contact us 📧 [email protected]