AI for en Indole struktur (N-Nitroso melatonin)

Apologies for replying in English, but there have been several discussions about nitrosated indoles recently!

For the nitrosated indoles, they aren’t nitrosamines per se; the indole nitrogen is not a secondary amine. Definitely still worth mentioning in the assessment if you consider there is risk of formation or have evidence thereof (don’t conceal anything is normally good advice!), but the implausibility of diazonium formation means that I would argue very strongly for treating these as conventional impurities under ICH M7 rather than as part of the cohort of concern.

I recently summarised this on another thread: 🗓 Nitrosamines Conversation Event w/ Dr. Raphael Nudelman - #13 by David

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