Olaparib Impurity 3 (CAS 61260-15-9) es una impureza relacionada estructuralmente con el principio activo que puede aparecer por rutas sintéticas incompletas o por degradación durante almacenamiento. Su identificación y cuantificación requieren métodos analíticos robustos como HPLC con detección UV | LC-MS para confirmación de masa y RMN para caracterización estructural. El perfil de impurezas debe evaluarse según ICH Q3A/Q3B | estableciendo límites de especificación y criterios de aceptación basados en riesgo toxicológico. El control incluye optimización de pasos de síntesis | purificación y condiciones de estabilidad | junto con métodos validados para asegurar cumplimiento regulatorio y seguridad del producto final.
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