Fenofibrate EP Impurity D (CAS 42019-07-8) é um derivado metílico relacionado ao fenofibrato | identificado como Methyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl-propanoate e também referido como Fenofibrate Methyl Ester Analog. Esta impureza deve ser rigorosamente monitorada pelo seu impacto no perfil de pureza | estabilidade e espectro de degradação do material de referência; sua origem costuma estar ligada a esterificação parcial | transesterificação ou impurezas de reagentes. Recomenda-se uso de métodos analíticos validados | como HPLC com detecção UV | LC-MS e comparação com padrão de referência para quantificação | definição de limites de aceitação conforme monografia EP e integração em procedimentos de controle de qualidade farmacêutico.
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