Impureza hidroximetilo de Upadacitinib presenta un grupo hidroximetilo introducido por oxidación parcial durante etapas de síntesis o almacenamiento; requiere vigilancia en el perfil de impurezas por su posible impacto en estabilidad y seguridad del producto. Su caracterización analítica se realiza mediante técnicas cromatográficas acopladas a espectrometría de masas y resonancia magnética nuclear para confirmar fórmula y puntos de fragmentación, complementadas con HPLC para cuantificación y límites de aceptación. Implementación de controles de proceso, especificaciones de lote y estudios de degradación acelerada son esenciales para minimizar su aparición y garantizar cumplimiento regulatorio en control de calidad farmacéutico.
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