I found it fascinating that inquiries about a particular topic come and go in waves… this week, we have received many inquiries about the availability of testing materials, limits, and even sources for structures that are NOT nitrosamines.
I’m not sure where the epicenter of the inquiry is, but please review the great knowledge exchange that took place a few months ago precisely on that topic here in the community.
Strangely, Naiffer, I have been asked too. But I did not hear about any agency inquiring about these. In fact the guidance from all agencies on CPCA clearly say that these are excluded from CPCA calculations. The nitrosamides/urea/carbamate/guanidine are all direct acting mutagens if they are stable. So, an Ames shoud solve the problem (or may be increase it). If asked, can you please share my white paper from Pharm. Tech. I had shared it with also my friends in regulatory agecies from the previous life and they had mentioned that the timing of the paper was good. Again, many of the nitrosamide group compounds are mutagenic and carcinogenic. But they dont need modified Ames test to show their mutagenicity. Nitrosamides–Should They Be Treated the Same as Nitrosamines?
