A impureza Capecitabine 3-O-BDR | CAS 1262133-64-1 | constitui um componente crítico do perfil de impurezas do capecitabina | sendo tipicamente observada como subproduto de síntese ou degradação. Sua identificação e quantificação por HPLC acoplada a LC-MS e confirmação por RMN são essenciais para estudos de estabilidade e ensaios de controle de qualidade. A presença desta impureza pode afetar a pureza global e requer definição de limites em conformidade com orientações ICH Q3A/Q3B. Estratégias analíticas robustas incluem padrões de referência | validação de método | acompanhamento durante desenvolvimento do processo e investigação de vias de formação para redução eficiente nos lotes.
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