Impureza Tofacitinib Benzyl Impurity (CAS 477600-73-0) | também referida como Tofacitinib Inhouse Impurity B ou Des-(N-oxopropanenitrile)-N-methylbenzyl | é uma impureza relacionada ao processo sintético de tofacitinibe caracterizada pela perda do substituinte N-oxopropanenitrile e pela presença de um grupo N-metilbencil. De interesse para controle de qualidade | apresenta massa e polaridade distintas que exigem métodos analíticos seletivos | como LC-MS/MS e HPLC com detecção por diodo. A compreensão de sua via de formação | estabilidade sob condições ácidas e básicas e comportamento em testes de validação é essencial para definição de limites de aceitação | métodos de quantificação e estratégias de purificação no desenvolvimento farmacêutico.
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