Genotoxic impurities

Genotoxic impurities

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.

As part of our commitment to provide the best analytical solutions to our customers and due to the market increasing demand on nitrosamine analysis we have recently improved our LC—MS/MS nitrosamine analytical method including the detection and quantitation of new nitrosamines. 

In addition, and thanks to the experience and expertise of our scientists in mass spectrometry, we have been able to increase sensitivity to achieve levels of detection and quantitation well below actual legal requirements.

Being aware that every drug product or drug substance may present different challenges we always perform method validation for each particular matrix. Moreover, our highly talented analytical method development team is willing to provide custom-made analytical solutions to the new needs that may arise from the nitrosamine risk assessments.

Method development and validation to include new nitrosamine species, APIs and pharmaceutical products in the scope of the methods is available on request.

 

Nitrosamines