Description

Ezetimibe Phenoxy Glucuronide is a major pharmacologically active metabolite of the cholesterol-lowering drug Ezetimibe. This compound is of critical importance for pharmaceutical research and development, particularly in the study of drug metabolism, pharmacokinetics, and bioanalytical method validation. It serves as a key reference standard for laboratories in the pharmaceutical and biotechnology sectors, ensuring accurate quantification and characterization of Ezetimibe and its metabolites in biological matrices.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the calibration of analytical instruments and validation of bioanalytical methods in compliance with GLP and ICH guidelines.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Essential for investigating the metabolic pathways, bioavailability, and elimination profile of Ezetimibe in preclinical and clinical research.
• Impurity Profiling and Control: Used to identify, quantify, and monitor this specific glucuronide conjugate as a metabolite impurity in active pharmaceutical ingredient (API) and finished drug product quality control.
• Bioequivalence and Clinical Trial Support: Critical for accurate measurement of metabolite levels in plasma/serum during bioequivalence studies and clinical trials for generic and innovator drug formulations.
• Academic and Contract Research: Serves as a vital reagent for universities and CROs (Contract Research Organizations) conducting fundamental research on lipid metabolism, transporter proteins, and glucuronidation processes.

Basic Information

Product Name	Ezetimibe Phenoxy Glucuronide
CAS No.	190448-57-8
Molecular Formula	C34H39NO9
Molecular Weight	605.68 g/mol
Synonyms	Ezetimibe Phenolic Glucuronide; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one 4-O-β-D-Glucuronide; Ezetimibe 4'-O-Glucuronide; Ezetimibe Glucuronide (Phenolic); SC-63514 Glucuronide; Zetia Metabolite
EINECS	Contact for details

Quality Control

Our Ezetimibe Phenoxy Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against established in-house reference standards. Our quality commitment ensures material suitability for demanding applications in regulatory filing and GMP/GLP-compliant environments.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dedicated freezer. The product is hygroscopic (moisture-sensitive); allow the sealed vial to equilibrate to room temperature before opening to prevent condensation. For long-term storage, consider under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular ion [M+H]+
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.