N-Nitroso Nilotinib (CAS 2925306-68-7), also designated N-Nitroso Nilotinib Impurity 1, is a nitrosamine-related process impurity of the tyrosine kinase inhibitor nilotinib. With molecular formula C28H21F3N8O2 and molecular weight 558.53 g/mol, it contains an N-nitroso functionality superimposed on the highly substituted heteroaromatic scaffold, consistent with nitrosation arising during synthesis or from exposure of amine precursors to nitrosating agents. As a potential genotoxic impurity, it falls within the risk-based assessment framework associated with ICH M7. Reliable characterization generally requires LC-MS/MS for trace-level quantification, supported by high-resolution MS and, where feasible, orthogonal LC-UV or GC-MS confirmation.
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