Impureza Capecitabina α-Isómero Diacetil é um subproduto estereoquímico observado durante síntese e armazenamento da capecitabina | caracterizado por dois grupos acetil ligados ao centro α isomérico. Esta impureza altera o perfil cromatográfico e pode impactar a pureza do princípio ativo | exigindo monitoramento rigoroso por HPLC com detecção UV e confirmação por LC-MS e RMN. Controles de processo incluindo otimização de condições reacionais | purificação por cromatografia e recristalização são recomendados para limitar sua formação. Estudos de estabilidade e estabelecimento de limites de especificação baseados em ICH e boas práticas analíticas asseguram conformidade regulatória e consistência do lote.
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