Description

Ent-Ezetimibe is the enantiomer of the widely used cholesterol-lowering agent Ezetimibe, serving as a critical reference standard and a key intermediate in pharmaceutical research and development. This compound is essential for analytical method development, impurity profiling, and the synthesis of novel therapeutic agents targeting the Niemann-Pick C1-Like 1 (NPC1L1) protein. It is primarily utilized by pharmaceutical R&D laboratories, analytical testing facilities, and fine chemical manufacturers engaged in the production of cardiovascular drugs and metabolic disorder treatments.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the identification, assay, and impurity testing of Ezetimibe in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Research: Critical for method development and validation in chromatographic techniques (HPLC, LC-MS) to study the pharmacokinetics and metabolism of Ezetimibe.
• Process Chemistry & Impurity Synthesis: Employed as a building block or precursor in the synthesis of related compounds and for generating specified impurities required for regulatory filings.
• Biochemical Research: Used in in-vitro studies to investigate the stereospecificity of the NPC1L1 protein and the mechanism of cholesterol absorption inhibition.
• Quality Control: Serves as a critical tool in quality control laboratories to ensure the enantiomeric purity of Ezetimibe batches.

Basic Information

Product Name	Ent-Ezetimibe
CAS No.	1376614-99-1
Molecular Formula	C24H21F2NO3
Molecular Weight	409.43 g/mol
Synonyms	(3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; (3R,4S)-Ezetimibe; Enantiomer of Ezetimibe; Ezetimibe Impurity; UNII-1L16K09L8B
EINECS	Contact for details

Quality Control

Our Ent-Ezetimibe is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chiral purity determination by HPLC, to ensure it meets the high standards required for pharmaceutical research. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming identity, purity, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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

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