Capecitabine Impurity 3 (CAS 216450-02-1) | também referida como Defluoro Capecitabine | é uma impureza de processo observada no desenvolvimento e estabilidade do capecitabine | caracterizada por perda de átomo de flúor na cadeia molecular. A identificação e quantificação são realizadas por HPLC acoplada a LC-MS e espectroscopia de RMN para assegurar identificação estrutural e limites de quantificação apropriados. Pode surgir por reação de desfluoração em etapas de síntese ou por condições degradativas | afetando perfis de pureza e conformidade regulatória ICH Q3A/Q3B. Estratégias de controle incluem otimização das condições reacionais | etapas de purificação e validação analítica robusta para monitoramento em lote e estudos de estabilidade.
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