Fenofibrate EP Impurity B, também denominada Fenofibrate Related Compound B e ácido fenofíbrico, corresponde ao CAS 42017-89-0 e apresenta fórmula molecular C17H15ClO4, com massa molar de 318,75 g/mol. Estruturalmente, trata-se do metabólito ácido carboxílico hidrolisado do fenofibrato, formado por clivagem do éster durante a síntese, o armazenamento ou a hidrólise oxidativa, e não por uma nova subestrutura química. Como impureza de processo e de degradação, sua elucidação geralmente requer LC-MS/MS para confirmação de identidade e LC-UV ou HPLC com comparação a padrão de referência para quantificação; GC-MS pode ser empregado após derivatização. Não é uma nitrosamina e, em geral, não se enquadra como impureza genotóxica na perspectiva da ICH M7.
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