Description

Ezetimibe Hydroxy-B-D-Glucuronide is a key 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 the development of analytical reference standards. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in bioequivalence studies, impurity profiling, and regulatory compliance activities.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the quantitative and qualitative analysis of Ezetimibe and its metabolites in biological matrices and finished dosage forms.
• Metabolite Identification & Profiling: Essential for ADME (Absorption, Distribution, Metabolism, Excretion) studies to understand the metabolic pathway of Ezetimibe.
• Impurity Standard: Used as a known impurity standard in the development and validation of HPLC/LC-MS methods to monitor and control the quality of Ezetimibe active pharmaceutical ingredient (API) and formulations.
• Bioanalytical Method Development: Critical for calibrating equipment and validating assays in pharmacokinetic and bioequivalence studies for generic drug applications.
• Pharmacology Research: Employed in preclinical and clinical research to investigate the activity and role of the glucuronidated metabolite.

Basic Information

Product Name	Ezetimibe Hydroxy-B-D-Glucuronide
CAS No.	536709-33-8
Molecular Formula	C34H41F2NO9
Molecular Weight	645.70 g/mol
Synonyms	Ezetimibe Glucuronide; Ezetimibe Hydroxy Glucuronide; Ezetimibe Phenolic Glucuronide; 1-(4-Fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone 4-O-β-D-Glucuronide; SCH 58235 Glucuronide; Zetia Metabolite; Ezetimibe Major Metabolite
EINECS	Contact for details

Quality Control

Our Ezetimibe Hydroxy-B-D-Glucuronide is manufactured under strict quality control protocols suitable for research and analytical applications. Each batch is characterized and tested using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure high purity and structural identity. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical data is provided with every shipment to support your regulatory and research requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines

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