Description

Ezetimibe Impurity 11 is a designated impurity standard used in the pharmaceutical development and quality control of the cholesterol-lowering drug Ezetimibe. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by analytical laboratories, pharmaceutical R&D teams, and quality assurance departments for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Ezetimibe API and its formulations.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and verifying chromatographic methods to accurately identify and quantify this specific impurity.
• Stability Indicating Method: Employed in forced degradation and long-term stability studies of Ezetimibe to monitor the formation of this impurity over time and under various stress conditions.
• Quality Control & Batch Release: A critical component in the QC testing of Ezetimibe batches to ensure impurity levels remain within International Council for Harmonisation (ICH) guidelines.
• Regulatory Submissions: Provides necessary data on impurity identity and levels for regulatory filings with agencies like the FDA, EMA, and other global health authorities.
• Research & Process Chemistry: Used by chemists to understand the formation pathway of this impurity during the synthesis of Ezetimibe, aiding in process optimization and impurity control.

Basic Information

Product Name	Ezetimibe Impurity 11
CAS No.	1607018-83-6
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; Ezetimibe Related Compound 11; Ezetimibe EP Impurity J; Ezetimibe USP Impurity; Ezetimibe Process Impurity; (3R,4S)-Ezetimibe Impurity; Azetidinone Impurity of Ezetimibe
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 11 is manufactured and analyzed under strict quality management systems. The material undergoes rigorous testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results against predefined specifications. Our quality commitment aligns with the standards expected for pharmaceutical reference materials.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified 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.