Brexpiprazole Nitroso Impurity 1, CAS 2639426-95-0, is the nitroso analogue of a piperazine-derived process-related impurity, formally designated piperazine,1-benzo[b]thien-4-yl-4-nitroso. With molecular formula C12H13N3OS and molecular weight 247.32 g/mol, it contains an N-nitroso functionality within a heterocyclic framework, a structural alert associated with potential mutagenic and genotoxic concern. Such species may arise during nitrosative side reactions, contamination by nitrosating agents, or oxidative transformation of secondary amine intermediates. Characterization typically requires LC-MS/MS, high-resolution LC-MS, and sometimes GC-MS after derivatization, with NMR used for structural confirmation under ICH M7 assessment.
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