Impureza enantiomérica de upadacitinib (CAS 1310726-59-0) representa un enantiomero residual que compromete la pureza quiral del principio activo; su identificación y cuantificación son críticas para garantizar la calidad del API. Caracterización técnico-analítica incluye HPLC quiral, cromatografía supercrítica chiral, RMN y espectrometría de masas para determinar configuración absoluta, exceso enantiomérico y perfil de degradación. Se requieren límites y especificaciones de impureza basados en estudios de estabilidad y toxicología, con métodos validados para LOD y LOQ y estudios de resolución en fase preparativa. El control de esta impureza es esencial para la consistencia del proceso sintético y cumplimiento regulatorio.
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