Capecitabine EP Impurity D (CAS 910129-15-6) | também referida como Capecitabine 2-Methylbutyloxy Impurity | é uma impureza resultante de O-alquilação parcial durante a síntese do princípio ativo. Seu monitoramento é essencial no controle de qualidade | pois influencia o perfil de pureza | a estabilidade e o risco toxicológico do API. Apresenta retenção característica em cromatografia líquida e é confirmada por LC-MS e RMN. Métodos validados de HPLC com detecção UV e espectrometria de massas são recomendados para quantificação e investigação de origem. A detecção oportuna permite otimizar processos sintéticos e atender especificações farmacopéicas.
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