Health Canada updated nitrosamine guidance

[chrischar]

Dear Kapilvaja,
The one you wrote about the limit of the N-nitroso-N-deshydroxyethyl-dasatinib is right but only if the dasatinib has indication only for advanced cancer. If a second indication is appeared in the SPC which is not correlated with advance cancer, then testing under ICHQ3B is not valid.
Please see also the Kisqali discussion, where our member ‘‘paliog’’ explain very nice why N-nitroso-Ribociclib should be tested as typical nitrosamine and not as common impurty.

Novartis pauses some trials of cancer drug Kisqali to fix manufacturing

The Swiss drugmaker said the stoppage is necessary to conform with new regulatory limits on nitrosamine, but will not affect commercial supply. The FDA has sought to reduce patient exposure to nitrosamine impurities over worries they might cause cancer in Ph-3 trials of breast cancer drug Kisqali. Kisqali 's API is ribociclib. N-nitroso -ribociclib impurity 1 is included in Appendix 1 as Category 3. [image] ribociclib

regards
Christos