Description

Ezetimibe Benzyl Impurity is a key process-related impurity and reference standard used in the pharmaceutical development and quality control of the cholesterol-lowering drug Ezetimibe. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a benchmark for analytical methods. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the benzyl impurity in Ezetimibe API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods to monitor impurity levels throughout the manufacturing process.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure Ezetimibe API meets stringent pharmacopeial (USP, EP) and ICH Q3A/B guidelines for impurities.
• Stability Studies: Used to track the formation and increase of this specific degradation product under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate control of the manufacturing process.
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this impurity, thereby improving yield and purity.

Basic Information

Product Name	Ezetimibe Benzyl Impurity
CAS No.	851860-29-2
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 Benzyl Ether; Ezetimibe Benzyl Ether; Ezetimibe Benzyl Derivative; Ezetimibe Related Compound B (Benzyl); Ezetimibe Impurity B (Benzyl); 1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-(benzyloxy)propyl]-4-(4-hydroxyphenyl)azetidin-2-one; UNII-7J9I4VW8QN
EINECS	Contact for details

Quality Control

Our Ezetimibe Benzyl Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, LC-MS for identity confirmation, and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with ICH Q3A, USP, and EP guidelines.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

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

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