Cephalexin Impurity 5 (CAS 1323247-65-9) é uma impureza associada ao processo de síntese da cefalexina | resultante de reações secundárias e degradação do anel beta-lactâmico; apresenta perfil cromatográfico e espectral distinto | sendo detectada e confirmada por HPLC-UV | LC-MS e RMN. Seu comportamento de degradação sob condições ácido-base e aquosas pode comprometer a pureza e a estabilidade do ingrediente ativo | exigindo investigação de causa-raiz. Recomenda-se controle por métodos analíticos validados | inclusão em perfil de impurezas e estabelecimento de limites de especificação para garantir qualidade e conformidade regulatória.
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