Impureza de Apixaban (CAS 503612-47-3) identificada como subproducto sintético o degradación relacionada que puede afectar la pureza del ingrediente farmacéutico activo. Su caracterización exige técnicas analíticas avanzadas como HPLC con detector UV | LC-MS de alta resolución y RMN para determinar estructura y niveles. Esta impureza suele originarse por rutas de síntesis incompletas o procesos de oxidación e hidrólisis durante almacenamiento. El control de calidad requiere establecer límites de especificación conforme a ICH Q3A | perfiles de impurezas relativas y métodos validados de cuantificación. Estrategias de mitigación incluyen optimización del proceso | purificación y condiciones de estabilidad controladas.
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