Description

Ezetimibe-13C6 is a stable isotope-labeled analog of the cholesterol absorption inhibitor Ezetimibe, specifically labeled with six carbon-13 atoms. This compound is an essential reference standard and internal standard for the accurate quantification and metabolic profiling of Ezetimibe in complex biological matrices using advanced analytical techniques. It is primarily utilized by pharmaceutical research and development laboratories, contract research organizations (CROs), and academic institutions engaged in pharmacokinetic studies, drug metabolism research, and bioanalytical method development.

Application

• Bioanalytical Reference Standard: Serves as a critical internal standard in Liquid Chromatography-Mass Spectrometry (LC-MS/MS) and Gas Chromatography-Mass Spectrometry (GC-MS) methods for the precise quantification of Ezetimibe in plasma, serum, and other biological fluids.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Used in mass spectrometry-based assays to track and quantify drug metabolites, enabling detailed studies on absorption, distribution, metabolism, and excretion (ADME).
• Clinical Research & Therapeutic Drug Monitoring (TDM): Facilitates the development and validation of robust analytical methods for monitoring Ezetimibe levels in patient samples during clinical trials.
• Pharmaceutical Quality Control: Employed as a certified reference material (CRM) for assay and impurity testing of Ezetimibe in active pharmaceutical ingredient (API) and finished dosage form manufacturing.
• Isotope Dilution Mass Spectrometry (IDMS): Acts as the ideal spike for IDMS, the gold-standard technique for achieving highest accuracy and traceability in quantitative analysis.
• Metabolomics Research: Enables differentiation between endogenous compounds and drug-derived metabolites in complex biological systems for pathway analysis.

Basic Information

Product Name	Ezetimibe-13C6
CAS No.	438624-68-1
Molecular Formula	C26H18F2NO3 (with six 13C atoms)
Molecular Weight	Approx. 416.4 g/mol (exact value depends on isotopic enrichment)
Synonyms	1-(4-Fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone-13C6; Ezetimibe (phenyl-13C6); Ezetimibe-13C6 (phenyl labeled); Zetia-13C6; SCH 58235-13C6; Isotopically Labeled Ezetimibe; Ezetimibe Internal Standard; [phenyl-13C6]Ezetimibe
EINECS	Contact for details

Quality Control

Our Ezetimibe-13C6 is manufactured under strict quality control protocols to ensure the highest isotopic and chemical purity for critical research applications. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic enrichment (Atom % 13C), chemical purity by HPLC, and confirmation of structure by NMR and MS. We adhere to relevant industry guidelines for reference standard materials. Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or CoA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccant in the container. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0% (chemical purity)
Isotopic Enrichment	≥99% Atom % 13C (at labeled positions)
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Specific Optical Rotation	Contact for details

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