Description

Ezetimibe Hydroxy-D4 -D-Glucuronide is a deuterated and glucuronidated metabolite of the cholesterol-lowering agent Ezetimibe. This compound is a critical reference standard and analytical tool for pharmaceutical research and development. It is primarily used by scientists and quality control laboratories in the pharmaceutical and biotechnology industries for drug metabolism and pharmacokinetic (DMPK) studies, bioanalytical method development, and clinical research.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the quantitative and qualitative analysis of Ezetimibe metabolites in biological matrices.
• Drug Metabolism & Pharmacokinetics (DMPK): Used in studies to understand the metabolic pathway, clearance, and exposure of Ezetimibe in preclinical and clinical settings.
• Bioanalytical Method Development: Essential for developing and validating sensitive LC-MS/MS or HPLC methods for therapeutic drug monitoring and pharmacokinetic profiling.
• Clinical Research & Biomarker Analysis: Enables accurate measurement of metabolite concentrations in patient samples during clinical trials.
• Impurity Profiling: Used to identify and quantify glucuronidated metabolite impurities in active pharmaceutical ingredient (API) batches.
• Stability Studies: Acts as a benchmark in studies investigating the stability of Ezetimibe and its metabolites under various conditions.

Basic Information

Product Name	Ezetimibe Hydroxy-D4 -D-Glucuronide
CAS No.	1426174-14-2
Molecular Formula	C38H43D4NO11
Molecular Weight	693.8 g/mol (approx.)
Synonyms	Ezetimibe D4 Glucuronide; Ezetimibe Hydroxy-D4 Glucuronide; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)-2-azetidinone Hydroxy-D4 Glucuronide; Ezetimibe Glucuronide-d4; Zetia Metabolite D4 Glucuronide; Deuterated Ezetimibe Glucuronide; Ezetimibe Metabolite M4-d4
EINECS	Contact for details

Quality Control

Our Ezetimibe Hydroxy-D4 -D-Glucuronide is manufactured under strict quality control protocols suitable for research and analytical use. Each batch is characterized and tested to ensure high chemical purity and isotopic enrichment. A comprehensive Certificate of Analysis (COA) is provided, detailing results for identity, purity (by HPLC), assay, and deuterium content. Our quality system supports compliance with relevant standards for reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below. This compound is hygroscopic (moisture-sensitive). Allow the vial to equilibrate to room temperature in a desiccator before opening to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Assay (HPLC)	≥ 98.0%
Deuterium Enrichment	≥ 98 atom % D
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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