La impureza Olaparib 46 es un componente detectado en el perfil de impurezas del proceso sintético de olaparib | relevante para control de calidad y evaluación regulatoria. Se caracteriza por análisis HPLC con detección UV y confirmación por LC-MS y espectrometría de masas de alta resolución | además de pruebas de RMN para asignación estructural. Su origen puede relacionarse con subproductos de acoplamiento o rutas de degradación durante purificación y almacenamiento. La identificación | aislamiento y estudio toxicológico permiten definir límites analíticos y criterios de aceptación conforme a ICH Q3A/Q3B. Se recomienda monitorizar su nivel mediante métodos validados y evaluar su estabilidad en condiciones de proceso.
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