A Tofacitinib Impurity TOF-IV, CAS 2227197-38-6, é uma impureza de processo definida associada ao arcabouço de tofacitinibe, e não um farmacóforo independente. Com fórmula molecular C14H21N5 e massa molecular de 259,35 g/mol, corresponde a um derivado amínico heteroaromático N-alquilado, compatível com formação durante a síntese em etapas ou por desproteção incompleta do núcleo pirrolo[2,3-d]pirimidínico. Essas substâncias relacionadas são avaliadas segundo princípios de qualificação de impurezas e, quando há alertas estruturais, pode ser necessária a apreciação de potencial genotóxico. A determinação em nível traço normalmente requer LC-MS/MS, espectrometria de massas de alta resolução e HPLC de fase reversa ortogonal com detecção por UV ou CAD.
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