A Impureza Amida de Upadacitinib é uma impureza orgânica relacionada ao processo, compatível com amidação ou rearranjo hidrolítico do arcabouço heteroaromático do fármaco de origem, sem pertença a uma classe estrutural associada a alertas genotóxicos diretos. Com fórmula molecular C15H18N6O e massa molecular de 298.34 g/mol, representa um degradante definido ou subproduto de síntese que pode surgir em etapas de acoplamento tardias, exposição à umidade ou reações de amidação. Sua caracterização обычно requer LC-MS/MS para confirmação de massa, associada a LC-UV e espectrometria de massas de alta resolução para discriminar análogos próximos. A avaliação regulatória segue princípios de qualificação de impurezas.
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