A impureza Dihydro Tofacitinib (CAS 1640972-35-5) | também conhecida como 5 | 6-Dihydro Tofacitinib | é um degradante estrutural relevante observado em processos de síntese e armazenamento de tofacitinibe | impactando o perfil de impurezas e a qualidade farmacêutica do produto final. Caracteriza-se por modificações no anel piperazínico que alteram comportamento cromatográfico e espectrométrico | exigindo métodos analíticos validados para quantificação e controle de qualidade. Sua formação é favorecida por condições redutoras ou por hidratação parcial | tornando essencial a monitoração por HPLC | LC-MS e RMN para investigação de vias de formação e estratégias de mitigação.
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