Olaparib Impurity 12 (CAS 763114-04-1) es una impureza relacionada del principio activo detectada durante estudios de síntesis y estabilidad. Se caracteriza mediante LC-MS | HPLC con detección UV y espectroscopía de RMN para identificación estructural y cuantificación precisa. Su comportamiento cromatográfico y patrones espectrales facilitan la separación y el análisis frente a degradados y otras impurezas. La presencia en niveles superiores a las especificaciones compromete la pureza del lote y obliga a acciones de mitigación | optimización del proceso sintético y controles de limpieza. Se recomienda definir límites analíticos | realizar evaluaciones toxicológicas y mantener un plan de monitoreo en control de calidad.
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