Description

Ezetimibe Impurity 72 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the cholesterol-lowering drug Ezetimibe by serving as a key marker for impurity profiling and control. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance. The precise characterization of this impurity is essential for meeting stringent pharmacopeial and regulatory compliance standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Ezetimibe drug substance and finished products.
• Impurity Profiling and Identification: Essential for method development and validation in HPLC, UPLC, and LC-MS to identify and quantify process-related impurities.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels against established specifications in accordance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products in Ezetimibe formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research and Development (R&D): Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation.

Basic Information

Product Name	Ezetimibe Impurity 72
CAS No.	2250240-87-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ezetimibe Related Compound 72; Ezetimibe EP Impurity J; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; UNII-7F6Q8W8Q8N; Ezetimibe Impurity 72 (EP); Ezetimibe Impurity J; Ezetimibe Degradant
EINECS	Contact for details

Quality Control

Our Ezetimibe Impurity 72 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH guidelines and relevant pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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