Tofacitinib Impurity C Citrate é uma impureza identificada no processo de síntese do tofacitinibe | registrada sob CAS 2174011-55-1 | que requer monitoramento rigoroso no perfil de impurezas. Caracteriza-se por propriedades fisicoquímicas e espectrais distintas | sendo determinável por HPLC com detectores UV | LC-MS para confirmação de massa e NMR para elucidação estrutural. Sua presença pode indicar reações secundárias ou degradação e impactar especificações de pureza e estabilidade. Estratégias de controle incluem otimização de etapas de reação | purificação cromatográfica e limites analíticos estabelecidos em métodos validados. Fornece dados críticos para controle de qualidade e conformidade regulatória.
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