Olaparib Impurity 25 (CAS 1423030-11-8) es una impureza relacionada del API que requiere monitoreo riguroso por su impacto potencial en el perfil de calidad. Químicamente caracterizable mediante HPLC y LC-MS | complementado con RMN para confirmación estructural | presenta un peso molecular y fragmentación distintivos que facilitan su trazabilidad analítica. Su control se integra en el perfil de impurezas según ICH Q3A/Q3B con límites de aceptación definidos por riesgo. La presencia de este componente puede influir en la estabilidad y en los ensayos de liberación | por lo que se recomienda métodos validados de cuantificación y estrategias de mitigación durante síntesis y purificación.
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