Fenofibrate USP Related Compound B ; Fenofibric Acid ;FENOFIBRATE EP IMPURITY B; Propanoic acid, 2-[4-(4-hydroxybenzoyl)phenoxy]-2-methyl; Hydroxy fenofibric acid (USP);
Descrição
Fenofibrate Impurity 5 (CAS 61002-27-5) é uma impureza relacionada ao fenofibrato | identificada como fenofibric acid derivative conhecida também como Fenofibrate USP Related Compound B; sua estrutura carboxílica aumenta a polaridade e a predisposição à formação por hidrólise | exigindo monitoramento rigoroso durante síntese e armazenamento. É detectada e quantificada por HPLC com detecção UV e confirmada por LC-MS e RMN para caracterização estrutural e identificação de isômeros. Controles de processo incluem limites de especificação | validação analítica e estudos de estabilidade sob condições ácidas e básicas. A gestão desta impureza é essencial para garantir qualidade e conformidade regulatória.
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