Description

3-o-Acetyl Ezetimibe-D4 is a deuterated analog of a key pharmaceutical intermediate, specifically designed for use as an internal standard in analytical chemistry. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative analyses, particularly in pharmacokinetic and metabolic studies. It is primarily utilized by research institutions, pharmaceutical development laboratories, and quality control departments requiring precise measurement of ezetimibe and its related substances.

Application

• Internal Standard for LC-MS/MS: Critical for the accurate quantification of ezetimibe in biological matrices (plasma, serum) during drug metabolism and pharmacokinetics (DMPK) studies.
• Pharmaceutical R&D: Used in the development and validation of analytical methods for ezetimibe-based drug formulations and generics.
• Bioanalytical Testing: Serves as a stable isotope-labeled reference standard in high-performance liquid chromatography (HPLC) and mass spectrometry assays to correct for instrument variability and sample preparation losses.
• Metabolite Tracing: Facilitates the study of ezetimibe's metabolic pathways and the identification of its metabolites in preclinical and clinical research.
• Quality Assurance & Control: Employed in GMP/GLP environments to ensure the purity, potency, and consistency of active pharmaceutical ingredients (APIs) and finished drug products containing ezetimibe.

Basic Information

Product Name	3-o-Acetyl Ezetimibe-D4
CAS No.	1217642-08-4
Molecular Formula	C24H17D4F2NO4
Molecular Weight	Approx. 421.43 g/mol
Synonyms	Ezetimibe-d4 3-O-Acetate; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-[(4-hydroxyphenyl)methyl]azetidin-2-one-3-O-acetate-d4; Deuterated Ezetimibe Acetate; Ezetimibe-D4 Acetate; Ezetimibe-3-O-acetyl-D4; Stable Isotope Labeled Ezetimibe Acetate; Internal Standard for Ezetimibe
EINECS	Contact for details

Quality Control

Every batch of 3-o-Acetyl Ezetimibe-D4 is manufactured and analyzed under strict quality management systems. We guarantee high chemical and isotopic purity, with comprehensive testing performed using advanced techniques like NMR, HPLC, and LC-MS. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity (typically >98% by HPLC), isotopic enrichment, and other critical specifications to meet the stringent requirements of pharmaceutical research and GLP compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); therefore, 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 structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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