Fenofibrate EP Impurity E (CAS 42019-08-9) | também conhecida como Fenofibrate Ethyl Ester Analog ou 2-[4-(4-clorobenzoyl)fenoxi]-2-metilpropanoato etílico | é uma impureza relevante no perfil de qualidade do fenofibrato. Este éster etílico pode ser identificado e quantificado por HPLC com detecção UV e confirmado por LC-MS e RMN. Sua formação é frequentemente atribuída a transesterificação ou etilação durante etapas de síntese ou processamento e pode aumentar a lipofilicidade e afetar a especificidade de ensaios. O controle envolve otimização das condições reacionais | etapas de purificação e limites de especificação conforme diretrizes ICH Q3A | além de métodos analíticos validados para monitoramento contínuo.
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