Fenofibrate EP Impurity B, también designada Fenofibrate Related Compound B y ácido fenofíbrico, corresponde al CAS 42017-89-0 y presenta fórmula molecular C17H15ClO4 con peso molecular de 318,75 g/mol. Desde el punto de vista estructural, es el metabolito ácido carboxílico hidrolizado de fenofibrato, originado por escisión del éster durante la síntesis, el almacenamiento o la hidrólisis oxidativa, y no por un andamiaje químico nuevo. Al tratarse de una impureza de proceso y de degradación, su caracterización suele requerir LC-MS/MS para la confirmación de identidad y LC-UV o HPLC con comparación frente a un patrón de referencia para la cuantificación; tras derivatización, GC-MS también puede resultar útil. No es un nitrosamina ni suele clasificarse dentro de las impurezas genotóxicas de ICH M7.
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