Bilastine Nitroso Impurity 1, also designated N-Nitroso Bilastine, is a nitrosamine-related process or degradation impurity associated with secondary amine nitrosation. Its CAS number is 2731008-04-9, and the assigned composition C12H14N4O corresponds to a molecular weight of 230.3 g/mol. As a structural nitrosamine, it is relevant to genotoxic impurity assessment under ICH M7 principles because N-nitroso species may exhibit DNA-reactive behavior. Trace-level determination generally requires orthogonal high-sensitivity methods, especially LC-MS/MS, often complemented by LC-HRMS for structure confirmation and, where volatility permits, GC-MS. Its presence may arise from nitrosating conditions during synthesis or storage.
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