Abiraterone Impurity 11 (CAS 165334-69-0) es una impureza relacionada con el proceso de síntesis del principio activo que presenta similitud estructural con abiraterona y puede afectar la pureza y estabilidad del lote. Su caracterización analítica se realiza mediante HPLC con detección UV | LC-MS para la confirmación de la masa molecular y RMN para la elucidación estructural y la identificación de grupos funcionales. El control de esta impureza requiere métodos validados de cuantificación | límites acordes a ICH y estrategias de purificación como cromatografía preparativa y recristalización. La monitorización temprana y la identificación oportuna permiten mitigar riesgos regulatorios y de calidad.
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