El Upadacitinib Des TFEA Carbamate Impurity (CAS 1428243-28-0) es una impureza orgánica relacionada con el proceso de síntesis de upadacitinib, originada por carbamoilación anómala o por la pérdida de la cadena lateral derivada de TFEA durante la conversión de intermedios. Con fórmula molecular C21H23N5O2S y peso molecular de 409.50 g/mol, corresponde a un componente no volátil y estructuralmente definido, más que a un simple producto de degradación. Su caracterización suele requerir LC-MS/MS para confirmar el ion molecular y LC-UV o HPLC con detección sensible a la masa para la cuantificación, con apoyo ortogonal de RMN cuando sea necesario. Por su origen específico de ruta, se evalúa dentro de los marcos de control de impurezas e ICH M7 según corresponda.
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