Abiraterone Related Compound 6 es una impureza estructuralmente relacionada con la molécula de abiraterona que puede generarse durante la síntesis | etapas de purificación o almacenamiento. Su presencia impacta el perfil de impurezas | la pureza de lote y potencialmente la estabilidad del producto final | por lo que requiere cuantificación y calificación. Se recomienda implementar métodos analíticos validados | incluyendo HPLC con detección UV y LC MS para identificación | además de qNMR para cuantificación absoluta y ensayos de degradación forzada para métodos indicativos de estabilidad. Las estrategias de control incluyen optimización de condiciones de reacción | controles de materias primas y límites de especificación basados en estudios toxicológicos y de impurezas.
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