Nitrosamine Impurities in Pharmaceuticals; Part-2

[@sivakumarbareddy4376]

Thank you for the information sir. I need a video that gives information how to fix SIM and MRM modes during quantification of Nitrosamomes.

[@drarvindmittal7353]

Nitrosamine impurity update: FDA Will Not Object to distribution of varenicline with Nitrosamine Below the Interim Acceptable Intake Limit. Varenicline is a prescription medication used to treat smoking addiction. To ensure patient access to varenicline, FDA will not object to distribution of varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 ng per day but below the interim acceptable intake limit of 185 ng per day until the impurity can be eliminated or reduced to acceptable levels.

[@VinodSharma-dx9gc]

very helpful lecture for current pharma requirements

[@drarvindmittal7353]

CHAMPIX (varenicline) Update by EMA www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-champix-varenicline-lots-be-recalled-due-presence_en.pdf