Description

Ezetimibe CAS NO 163222-33-1 is a selective cholesterol absorption inhibitor, a key active pharmaceutical ingredient (API) in the treatment of hypercholesterolemia. Its primary value lies in its unique mechanism of action, which blocks the absorption of dietary and biliary cholesterol at the brush border of the small intestine without affecting the uptake of triglycerides or fat-soluble vitamins. This product is essential for pharmaceutical manufacturers and research institutions developing and producing lipid-lowering medications. It is a critical component in combination therapies and single-agent formulations aimed at managing cardiovascular disease risk.

Application

• Pharmaceutical API: Primary use as the active ingredient in finished dosage forms for the treatment of primary hypercholesterolemia, homozygous sitosterolemia, and homozygous familial hypercholesterolemia.
• Fixed-Dose Combination Drugs: Used in combination with statins (e.g., Simvastatin, Atorvastatin) in single-tablet therapies to provide dual-action cholesterol management.
• Clinical Research: Serves as a reference standard and investigational material in pharmacokinetic, pharmacodynamic, and new formulation studies.
• Generic Drug Manufacturing: A vital component for companies producing bioequivalent generic versions of branded ezetimibe medications.
• Veterinary Medicine Research: Investigated for potential applications in managing lipid disorders in companion and livestock animals.

Basic Information

Product Name	Ezetimibe
CAS No.	163222-33-1
Molecular Formula	C24H21F2NO3
Molecular Weight	409.43 g/mol
Synonyms	Ezetimibe; 1-(4-Fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)-(4-hydroxyphenyl)-2-azetidinone; SCH 58235; Zetia (brand name); Ezetrol; Ezetimibum; Ezetimiba; Lipidia
EINECS	Contact for details

Quality Control

Our Ezetimibe is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent pharmacopeial standards, including USP and EP monographs where applicable. Key parameters such as identity, purity, related substances, residual solvents, and microbial limits are rigorously controlled. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance for our global pharmaceutical partners.

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. For long-term storage, consider desiccants or inert atmosphere packing.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.5%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 0.5%
Sulfated Ash	≤ 0.1%
Microbial Enumeration	Meets Ph. Eur. 2.6.12 / USP <61>

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