Enhancing Nitrosamines Analysis: A Focus on Nitroso Drug Substance-Related Impurities (NDSRIs)

The first alert from regulatory authorities was in mid-2018 when nitrosamine impurities - including N-nitrosodimethylamine (NDMA) - were detected in sartans-based pharmaceutical products. This triggered a series of global-scale investigations that led to the revelation of the presence of other low molecular weight N-nitrosamines in many APIs and finished products, sometimes forcing companies to recall products. Successively, a new risk was highlighted related to the formation of NDSRIs from APIs (or their related impurities) containing vulnerable amine groups during finished product formulation/storage due to the reaction with residual nitrite present in some raw materials. This new emerging issue affected several drug products on the market, stimulating the Competent Authorities to push for a review of the original risk assessment in light of this new information performing step 2 confirmatory testing as appropriate.
Our scientific expert will talk about:

• NDSRIs emerging issues
• Analytical challenges during method development and QC tests on NDSRIs
• Case studies from Mérieux NutriSciences Pharma Nitrosamines Labs