Impurities with genotoxic potential must be evaluated on a risk-based approach and controlled at levels much lower than typical organic impurities. Only laboratories owing the most advanced analytical instrumentation can achieve the performance required by regulatory bodies.
Nitrosamines have recently emerged as a special challenge for manufacturing and QC farma players with an increasing number of nitrosamine species detected, in many different APIs and with different sources identified.
GC-MS/MS and HPLC-MS/MS validated methodologies are available based on public internationally recognized protocols.
Method development and validation to include new nitrosamine species, APIs and pharmaceutical products in the scope of the methods is available on request.