Abiraterone Related Compound 8 es una impureza relacionada con abiraterona que surge durante etapas de síntesis y purificación. Presenta un perfil cromatográfico y espectrométrico distintivo que requiere identificación y cuantificación mediante HPLC-UV acoplado a LC-MS para asegurar selectividad y sensibilidad. Su caracterización estructural se confirma por RMN y espectrometría de alta resolución | permitiendo evaluar posibles modificaciones funcionales que afecten estabilidad y seguridad del principio activo. El control de proceso y los límites de aceptación se establecen conforme a directrices ICH para impurezas | e incluyen estrategias de remoción | monitoreo en lote y documentación para garantizar cumplimiento regulatorio y calidad del producto final.
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