A impureza diastereomérica Tofacitinib Citrato (isómero 3RS | 4SR) é um subproduto estereoespecífico gerado durante a síntese do API que exige monitorização rigorosa. Caracteriza-se por configuração 3RS | 4SR e propriedades fisicoquímicas que diferem do isómero desejado | influenciando chiralidade | solubilidade e perfil cromatográfico. Estratégias analíticas para identificação e quantificação incluem HPLC quiral | LC-MS | RMN e avaliação de pureza por UHPLC com padrões de referência. Controles de processo e desenvolvimento de métodos de isolamento e enriquecimento minimizam sua presença no lote final. Avaliação de estabilidade | toxicidade e limites aceitáveis são parte das práticas de controle de qualidade e conformidade regulatória.
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