3-O-Acetyl ezetimibe

3-O-Acetyl ezetimibe is a fluorinated, acetylated derivative of ezetimibe, characterized by a tetrahydrofuran ring fused to a phenyl ring, substituted with a trifluoromethyl group and an acetylated hydrazide moiety. The 3-hydroxyl group of ezetimibe is esterified with acetic acid, introducing an additional ester functionality. This compound arises as a process-related impurity during the synthesis of empagliflozin, likely due to acetylation side reactions in shared intermediate pathways. It serves as an HPLC reference standard for quantifying acetylation byproducts in empagliflozin active pharmaceutical ingredient (API) batches.