Impureza 5 de dienogest | una mezcla de diastereómeros | presenta variación estereoquímica que puede afectar la pureza y propiedades farmacológicas del lote. Su identificación y cuantificación requieren técnicas analíticas avanzadas como LC-MS | RMN y cromatografía en fase alta resolución con condiciones validadas para separar diastereómeros. Se recomienda desarrollar métodos de control que incluyan límites basados en toxicología y perfil de degradación | así como estudios de estabilidad forzados para determinar su origen durante síntesis o almacenamiento. La comprensión de su espectro de masas | tiempos de retención y constantes de acoplamiento facilita la implementación de medidas de mitigación en procesos de fabricación y liberación.
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