La impureza diamina de vareniclina, CAS 230615-69-7, corresponde al subproducto relacionado con el proceso 2,3,4,5-tetrahidro-3-(trifluoroacetil)-1,5-metano-1H-3-benzazepina-7,8-diamina. Con fórmula molecular C13H14F3N3O y peso molecular de 285.26 g/mol, su presencia sugiere conversión incompleta o rutas laterales durante la síntesis de vareniclina, en particular en etapas de aminación e introducción del grupo trifluoroacetilo. La estructura azabicíclica rígida con aminas aromáticas vecinales modifica el comportamiento cromatográfico y la ionización. Su determinación a nivel traza suele requerir LC-MS/MS, LC-UV con confirmación ortogonal y, cuando procede, MS de alta resolución en el contexto de una evaluación alineada con ICH M7.
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