Impureza de Upadacitinib N1-metil éster es un subproducto metilado observado en etapas intermedias y en el perfil de impurezas del proceso de síntesis de Upadacitinib. Presenta propiedades fisicoquímicas y espectrales específicas que requieren identificación por HPLC con detección UV, LC-MS para determinación de masa y RMN para confirmación estructural. Su formación suele asociarse a reacciones de metilación inadvertida o degradación durante condiciones ácidas o básicas en síntesis. El control analítico mediante cromatografía con tiempo de retención definido, límites de aceptación según ICH Q3A y estrategias de mitigación como optimización de condiciones de reacción y purificación garantizan su eliminación por debajo de umbrales regulatorios.
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