Fenofibrate USP Related Compound B ; Fenofibric Acid ;FENOFIBRATE EP IMPURITY B; Propanoic acid, 2-[4-(4-hydroxybenzoyl)phenoxy]-2-methyl; Hydroxy fenofibric acid (USP);
Descripción
Fenofibrate Impurity 5 (CAS 61002-27-5) es una impureza relacionada con fenofibrato conocida como Fenofibric Acid o Fenofibrate USP Related Compound B. Químicamente es un ácido propanoico sustituido con un grupo hidroxi en el anillo fenílico | y suele originarse por hidrólisis o oxidación del éster parent. Su identificación y cuantificación requieren métodos cromatográficos y espectrométricos sensibles como HPLC-UV y LC-MS con condiciones estabilidad indicadoras. El control en lote incluye límites de especificación | perfiles de impurezas y estudios de degradación forzados para garantizar cumplimiento de normas ICH y minimizar impactos en seguridad y calidad del producto final.
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