A Upadacitinib N1-Tosyl Impurity (CAS 2411540-30-0) é uma impureza relacionada ao processo, resultante de N-sulfonilação no nitrogênio da pirrolidina do arcabouço inibidor de JAK1. Com fórmula molecular C24H25F3N6O3S e massa molar de 534.55 g/mol, trata-se de um subproduto sintético estruturalmente definido, e não de um simples degradante. O substituinte tosila aromático altera polaridade e comportamento de ionização, de modo que sua caracterização normalmente exige LC-MS/MS com confirmação por MS de alta resolução, além de HPLC-UV e, quando necessário, RMN. Seu controle é pertinente ao perfil de impurezas segundo ICH Q3A/Q3B e pode demandar avaliação adicional em contexto de impurezas genotóxicas.
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