Tofacitinib Impurity 38 é um candidato a impureza processual identificado durante o perfil de pureza de lotes de tofacitinibe. Caracterizada por cromatografia líquida com detecção UV e LC-MS para massa exata | apresenta tempo de retenção e espectro de massa distintos do princípio ativo. Estudos de degradação forçada e reação de intermediários sugerem formação por rearranjo do intermediário amínico ou oxidação parcial. A identificação estrutural foi confirmada por RMN e espectrometria de massas de alta resolução. Estratégias de controle incluem investigação de via sintética | otimização de etapas de purificação | limites de especificação | e desenvolvimento de método quantitativo validado conforme ICH Q3A para monitoramento em matéria-prima e produto acabado.
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