Varenicline Diamine Impurity, CAS 230615-69-7, is the diamine-associated process-related impurity 2,3,4,5-tetrahydro-3-(trifluoroacetyl)-1,5-methano-1H-3-benzazepine-7,8-diamine. With molecular formula C13H14F3N3O and molecular weight 285.26 g/mol, it reflects incomplete conversion or side-reaction pathways during varenicline synthesis, particularly around amination and trifluoroacetyl introduction. The structure contains a rigid azabicyclic benzazepine core bearing adjacent aromatic diamines, which may alter chromatographic behavior and ionization response. Trace-level assessment typically relies on LC-MS/MS, LC-UV with orthogonal confirmation, and, where needed, high-resolution MS for impurity profiling under ICH M7-relevant evaluation.
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