Olaparib Impurity 28 es una impureza identificada en el perfil de degradación del fármaco Olaparib. Esta impureza presenta una estructura relacionada que puede originarse durante etapas de síntesis o por degradación térmica y oxidativa. Su detección exige métodos analíticos sensibles como HPLC con detección UV y LC-MS para confirmación de masa y fragmentación. La cuantificación precisa y la evaluación de su estabilidad son críticas para el control de calidad y la validación analítica | incluyendo límites de detección y recuperación. La caracterización espectroscópica y estudios de forzado apoyan el establecimiento de especificaciones y estrategias de mitigación durante desarrollo farmacéutico.
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