Description

Ezetimibe Impurity 36 is a high-purity chemical reference standard used in pharmaceutical research, development, and quality control. This compound is critical for the accurate identification, quantification, and monitoring of process-related impurities during the synthesis of the cholesterol-lowering drug Ezetimibe. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation in API (Active Pharmaceutical Ingredient) manufacturing.
• Quality Control & Assurance: Used in HPLC, LC-MS, and other chromatographic systems to establish impurity profiles and ensure batch-to-batch consistency of Ezetimibe.
• Regulatory Compliance & Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA, ICH guidelines) by providing a characterized impurity for stability studies and specification setting.
• Research & Development: Serves as a critical tool in synthetic route optimization and degradation studies to understand the formation and control of this specific impurity.
• Pharmacopoeial Testing: Potential use as a system suitability standard in compendial testing methods aligned with USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Ezetimibe Impurity 36
CAS No.	1809031-15-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ezetimibe Related Compound 36; Ezetimibe EP Impurity G; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; UNII-7J7E9K3F2R; 7J7E9K3F2R; Azetidin-2-one, 1-(4-fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)-, (3R,4S)-
EINECS	Contact for details

Quality Control

Our Ezetimibe Impurity 36 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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