Fenofibrate EP Impurity D is a degradation byproduct arising from the hydrolytic cleavage of the glycerol ester moiety in fenofibrate, resulting in the exposure of a free carboxylic acid group. Its structure retains the core phenoxyphenylpropanoic acid scaffold with an isopropyl substitution at the ฮณ-position, while lacking the triazole linkage characteristic of the parent API. This impurity exhibits enhanced polarity due to the de-esterified carboxylate, facilitating distinct chromatographic behavior. It serves as an HPLC reference standard for quantifying degradation pathways in fenofibrate formulations.
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