Varenicline Impurity 15 (CAS 2803960-64-5) | identificado como 3-nitroso-2 | 3 | 4 | 5-tetrahidro-1H-1 | 5-metanobenzo[d]azepina-7 | 8-diamina | es una impureza nitrosa reportada en etapas de síntesis de vareniclina que requiere control analítico riguroso; presenta propiedades polares y baja volatilidad que dificultan su eliminación por destilación y por tanto se monitoriza mediante HPLC y LC-MS/MS con métodos validados de alta sensibilidad; su presencia se limita según criterios toxicológicos y guías regulatorias como ICH M7; las estrategias de mitigación incluyen optimización de condiciones de reacción | purificación por cromatografía y uso de estándares de referencia para cuantificación precisa.
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