Impureza identificada como Varenicline Ortho Dinitro Impurity | CAS 230615-59-5 | también referida por el nombre 2 | 2 | 2-trifluoro-1-(1 | 2 | 4 | 5-tetrahidro-7 | 8-dinitro-1 | 5-metano-3H-3-benzazepin-3-il)etanona | es un subproducto nitroaromático con marcado carácter electronegativo por los grupos nitro y trifluorometilo; su presencia impacta perfiles de pureza y estabilidad del API. Se recomienda su monitorización mediante HPLC-UV con confirmación por LC-MS y caracterización por RMN para límites de identificación y cuantificación conforme a ICH Q3A/B. Su origen suele ser reacciones de nitración y pasos de oxidación incompleta. Se sugiere control en lote | estandarización de referencia y condiciones de almacenamiento que minimicen degradación.
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