Fenofibrate EP Impurity B, also designated Fenofibrate Related Compound B and fenofibric acid, corresponds to CAS 42017-89-0 and has molecular formula C17H15ClO4 with molecular weight 318.75 g/mol. Structurally, it is the hydrolyzed carboxylic acid metabolite of fenofibrate, arising from ester cleavage during synthesis, storage, or oxidative hydrolysis rather than from a novel scaffold. Because it is a process- and degradation-related impurity, its characterization generally relies on LC-MS/MS for identity confirmation and LC-UV or HPLC with reference comparison for assay determination; GC-MS may be used after derivatization. It is not a nitrosamine and is not typically discussed under ICH M7 genotoxic impurity classes.
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