400 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-varenicline (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.
Description
Varenicline Nitrosamine VRN-5000 Impurity, also designated Varenicline Impurity 9 and N-Nitroso Varenicline, is a nitrosamine-related process or degradation impurity associated with the varenicline scaffold. CAS 2755871-02-2; molecular formula C13H12N4O; molecular weight 240.26 g/mol. As an N-nitroso species, it warrants consideration under nitrosamine risk assessment and ICH M7 principles because such entities may present mutagenic concern at trace levels. Structural confirmation and quantification typically rely on LC-MS/MS, with complementary high-resolution MS and, where appropriate, GC-MS after derivatization or concentration. Its presence may arise from nitrosating conditions during synthesis, workup, or storage.
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