Description

Ezetimibe-D4 is a deuterated analog of the cholesterol absorption inhibitor Ezetimibe, specifically labeled with four deuterium atoms. This stable isotope-labeled compound is a critical reference standard and internal standard for the accurate quantification and metabolic profiling of Ezetimibe in complex biological matrices. It is essential for researchers and quality control laboratories in the pharmaceutical industry who require high-purity materials for bioanalytical method development, pharmacokinetic studies, and ensuring regulatory compliance in drug development and manufacturing.

Application

• Primary use as an Internal Standard for the precise quantification of Ezetimibe in biological fluids (plasma, serum) using LC-MS/MS and GC-MS methods.
• Metabolite Identification and Profiling studies to track the distribution and biotransformation pathways of Ezetimibe.
• Development and validation of Bioanalytical Assays in accordance with FDA, EMA, and ICH guidelines for clinical and non-clinical trials.
• Use in Pharmaceutical Quality Control for the analysis of drug substances and products to ensure potency and purity.
• Application in DMPK (Drug Metabolism and Pharmacokinetics) research to understand the absorption, distribution, metabolism, and excretion of Ezetimibe.
• As a critical component in Stable Isotope Dilution Mass Spectrometry (SID-MS) for achieving the highest accuracy in quantitative analysis.

Basic Information

Product Name	Ezetimibe-D4
CAS No.	1093659-90-5
Molecular Formula	C24H17D4F2NO3
Molecular Weight	409.44 g/mol (for monoisotopic mass)
Synonyms	1-(4-Fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone-d4; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one-d4; Ezetimibe (phenyl-d4); Ezetimibe-d4; Deuterated Ezetimibe; SCH 58235-d4; Zetia-d4 (labeled analog)
EINECS	Contact for details

Quality Control

Our Ezetimibe-D4 is manufactured under controlled conditions to ensure exceptional isotopic and chemical purity, meeting the stringent requirements for use in regulated bioanalysis. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for isotopic purity (D-enrichment), chemical purity by HPLC, residual solvent content, and identity confirmation (IR, MS). We adhere to a rigorous quality management system, and our products are suitable for use in methods developed under GLP and cGMP guidelines.

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); the container must be kept tightly sealed in a dry environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 98.0%
Water Content (KF)	≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C

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