Capecitabine Impurity 13 (CAS 62211-93-2) é uma substância relacionada identificada durante o desenvolvimento e controle de qualidade de capecitabina. Esta impureza é monitorada em estudos de síntese | purificação e estabilidade | e requer caracterização analítica robusta por HPLC | LC-MS e RMN para confirmação estrutural e quantificação. Sua presença influencia estabelecimento de limites de especificação e justificativas conforme diretrizes ICH Q3A/Q3B. Fornecida com documentação analítica | loteamento e certificação de pureza | esta impureza é destinada a laboratórios que realizam perfilamento de impurezas | investigação de vias de degradação e validação de métodos analíticos.
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