Nitrosamine impurities in pharmaceutical products are considered a matter of concern even at trace levels as they are classified mutagenic carcinogens. Sensitivity and selectivity of the analytical methods used to detect and quantitate these impurities are key in order to fulfil the regulatory requirements and to avoid false positive, non-compliant results. Different approaches can be used for nitrosamine determination, beside the classic regulated targeted analysis on GC-MS and LC-MS nominal mass system, we also cover methods using high resolution accurate mass spectrometry (HRAM) systems. These GC- and LC-HRAM-MS methods can provide reliable and comprehensive information on nitrosamines impurities that may be present in pharmaceutical products. In this webinar we will discuss the advantages of each powerful approach and how they address the challenges of nitrosamine analysis.
Overview of current regulatory landscape for genotoxic impurities
Analytical challenges with analysis of nitrosamine impurities overcome by LC-MS and GC-MS
Utilization of high-resolution accurate mass (HRAM) mass spectrometry systems for increased confidence in data