Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs)

Dr. Ashworth published a new paper related to NDSRIs. I can only read the abstract now, and it seems to refer to IQ consortium/EFPIA’s three conditions for NDSRIs manufacturing.

If an N-nitrosamine is formed under these reaction conditions, the information gained can be used as part of the risk assessment and also provides a starting point for the development of a process to synthesize a discrete sample for further testing. Additionally, synthetic and analytical considerations that should be taken into account during preparation of novel N-nitrosamines for use in analytical or toxicological studies are discussed.


It’s a fantastic paper!! We should take into consideration that stability of nitrosamines in solution, contamination of c-nitrosated compounds, contamination of different kinds of nitrosamines, and the rotational isomerism of nitrosamines.

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