EMA nitrosamine Q&A Appendix 1 rev.7 published on Dec 13, 2024

[Yosukemino]

Dear @elenipoliti,

Thank you for asking. I agree with Mircea. You might confuse other N-nitroso compounds (ex. N-nitroso-indoles) with nitrosamines. The EMA separated other N-nitroso compounds from nitrosamines in the document. They are not considered nitrosamines because they have different characteristics from nitrosamines. The following thread helps you understand the key points.

Imidazole is a secondary amine?

Dear all, How would you consider this structure below (2-Methylimidazole): [Captura imidazole] Could it be considered as a secondary amine source? or would it be outside of the scope of nitrosamine guidelines? Thanks in advance! Victoria

Yosuke