Nitrosourea, aromatic n-nitroso copmounds

Guidance, Documents, Resources
1

Hello All,
is there any update on EMA’s guidelines to set AI limits for nitrosamide, nitrosourea or aromatic nitrosamine impurities (impurities that are excluded from the CPCA approch), is there any reference?

2

hi. I trust that you have already checked the Appendix 1 for “other nitrosocompounds” right?
kind regards.