Nitroso quinazoline can form?

[Riccardo]

Hi to everybody
I read a lot your interesting threads but this is the first time I post a topic

On a risk assessment in the RSM preparation steps we hypothyzed the formation of this impurity, by reaction of the corresponing idrazine compound with H2O2, which is used in the process to remove the excess of hydrazine.

This nitrosated impurity is a nitroso-amidine (not a nitrosamine) but anyway potentially genotoxic.
An article in literature (Chem. Pharm. Bull. 72, 166–172 (2024)) reported the formation of nitroso compounds of Indapamide and Gliclazide starting from 1,1-disubstituted hydrazines, but structures were different compared to the amidine reported above.
Do you believe the formation of the above amidine is possibile?

Thank you

[jason.brown]

I would start with the question of whether or not this should be/is in the cohort of concern. I would only worry about formation if that is the case. So, after showing that, I would look to perform the modified NAP test and see what you will see. You won’t be able to rely on the pontification of the fine contributors here.