Olaparib Impurity 23 es una impureza identificada en lotes de olaparib que presenta un perfil fisicoquímico definido por mayor polaridad y masa molecular ligeramente modificada respecto al principio activo. Se detecta mediante técnicas analíticas LC-MS y UPLC con límites de detección en el rango de trazas | y su cuantificación se realiza por HPLC con control por gradiente y estándares internos. Su formación se asocia a rutas de degradación oxidativa y reacciones secundarias en condiciones de síntesis y almacenamiento. La caracterización estructural y el establecimiento de especificaciones son esenciales para la gestión de riesgos | el desarrollo de límites de aceptación y estrategias de purificación robustas.
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