As EMA was starting to look at nitrosamides, I wrote a white paper in a hurry to indicate that these are not nitrosamines but “Nitrosamides”. I have a posting here “Nitrosamides - horse of a different color”. These products are direct acting carcinogens and should not be treated as nitrosamines. So, you can do a general Ames assay to see if they are positive. also, treat them as mutagenic impurity and use SAR. Most of them will have higher limits. Again, they are not nitrosamines. So, dont apply any nitrosamine related limits to these. Also, they dont have to meet any nitrosamine related deadlines.
Nitrosamides–Should They Be Treated the Same as Nitrosamines?
Published on: October 15, 2022
Aloka Srinivasan, Chuck Lambert
Pharmaceutical Technology, Pharmaceutical Technology, Trends in Formulation, October 2022, Volume 2022 eBook, Issue 3
Pages: 42–50
check my paper Nitrosamides–Should They Be Treated the Same as Nitrosamines?