Description

(3'R)-Ezetimibe CAS NO 163380-16-3 is the specific stereoisomer of the cholesterol absorption inhibitor Ezetimibe, a key pharmaceutical intermediate. This compound is critical for ensuring the precise stereochemistry required for the efficacy and safety of the final active pharmaceutical ingredient (API). It is essential for manufacturers in the pharmaceutical industry engaged in the synthesis of high-purity, regulatory-compliant cholesterol-lowering medications.

Application

• Pharmaceutical Intermediate: Primary building block in the synthesis of the cholesterol-lowering drug Ezetimibe.
• Active Pharmaceutical Ingredient (API) Development: Used in research and development for creating and optimizing final drug formulations.
• Process Chemistry & Scale-Up: Serves as a critical starting material or intermediate in pilot plant and commercial manufacturing processes.
• Reference Standard: Acts as a chromatographic and spectroscopic standard for quality control and analytical method development.
• Regulatory Filings: Supplied for use in generating data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for production under cGMP guidelines.

Basic Information

Product Name	(3'R)-Ezetimibe
CAS No.	163380-16-3
Molecular Formula	C24H21F2NO3
Molecular Weight	409.43 g/mol
Synonyms	(3R)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; (3R,4S)-Ezetimibe; Sch 58235 Isomer; Zetia Intermediate; Ezetimibe (3'R) Isomer; (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone
EINECS	Contact for details

Quality Control

Our (3'R)-Ezetimibe is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and chiral purity, to ensure it meets stringent pharmaceutical-grade specifications. Certificates of Analysis (COA) detailing all test results are provided and can be tailored to support regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥98.5%
Chiral Purity (Chiral HPLC)	≥99.0%
Related Substances (HPLC)	Total impurities ≤1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤0.5%

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