Impureza de olaparib 61 (CAS 59878-57-8) | nombrada 2-methyl-1-(piperazin-1-yl)propan-1-one | es un contaminante relevante en el control de calidad de lotes farmacéuticos. Químicamente definida y caracterizable por LC-MS | HPLC y RMN | su presencia puede indicar desviaciones en etapas de síntesis o degradación durante la formulación. Su perfil analítico y límites aceptables deben establecerse para minimizar efectos sobre pureza y estabilidad del principio activo. Se recomienda implementar métodos validados para cuantificación y establecer estrategias de control en proceso y especificaciones de liberación para asegurar cumplimiento regulatorio y consistencia de producto.
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