Tofacitinib Impurity V (CAS 1616761-00-2) | também conhecida como 2-cloro-tofacitinib ou N-metil-N-(3R | 4R)-1-cianoacetil-4-metilpiperidin-3-il-2-cloro-7-deazapurina-6-amina | é uma impureza de síntese identificada no perfil analítico de lotes de tofacitinibe. Caracteriza-se pela substituição de cloro e presença do grupo cianoacetil | apresentando massa e comportamento cromatográfico distintos. É detectável e quantificável por LC-MS | HPLC-UV e espectroscopia de RMN e requer qualificação toxicológica e controle conforme diretrizes ICH. Estratégias de mitigação incluem otimização da etapa de cloração | purificação por cromatografia e definição de limites de especificação e de método de quantificação para garantir conformidade regulatória e estabilidade do ingrediente farmacêutico ativo.
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