Capecitabine Impurity 15 (Mistura de Diastereômeros) é uma impureza quimicamente relacionada à capecitabina que apresenta perfis de estereoquímica múltipla | afetando propriedades físico-químicas e comportamento cromatográfico. A identificação e quantificação exigem técnicas analíticas robustas como HPLC com detecção UV | LC-MS e RPLC chiral quando necessário | além de RMN para elucidação estrutural. Avaliação de estabilidade | limites de aceitação e vias de formação durante síntese ou degradação são cruciais para controle de qualidade e validação de processo. Informações sobre solubilidade | temperatura de decomposição e possível conversão epimérica suportam estratégias de mitigação e conformidade regulatória.
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