Sufentanil Nitroso impurity standard

[Naiffer_Host]

@Sciandra, have you tried to reproduce the nitrosating conditions of your formulation in the lab to assess the reaction and yield of nitrosamine formation (if any)?

Please take a look at Ashworth et al for a very comprehesive approach :

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

Dear Team, A nice publication from group of Pharmaceutical industries that discussed challenges in NDSRIs synthesis and how same can be used in risk assessment justification. It has also thrown light on taking care of quality of NDSRI that to be taken forward for analytical and toxicological testing https://www.sciencedirect.com/org/science/article/abs/pii/S1083616023001652 [image]