@GENERAPHARM Thank you for your comments. I agree with you. As @ASrinivasan mentioned in GDSR this year, lots of API are with nitrosatable amines.
D1S10-1-Srinivasan_p8.pdf (263.5 KB)
I’m not sure the results of the risk assessment of these drugs, however those should be carefully handled. And varenicline (Chantix) is voluntarily recalled due to the risk of nitrosamine impurity contamination. It has a secondary amine.