Description

Ezetimibe Impurity 71 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of Ezetimibe, a widely prescribed cholesterol-lowering medication. It is primarily utilized by analytical chemists and quality assurance professionals in the pharmaceutical industry for method development, validation, and impurity profiling. Ensuring the integrity of this impurity standard is fundamental to maintaining drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Ezetimibe Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Regulatory Submissions: Essential for preparing impurity profiles and supporting documentation required for drug master files (DMFs), ANDAs, and other regulatory filings with agencies like the FDA and EMA.
• Stability Studies: Used to track the formation of this specific impurity during forced degradation and long-term stability testing of Ezetimibe formulations.
• Research & Development: Aids in synthetic route optimization and process chemistry by helping to identify and control the formation of this impurity during API manufacturing.

Basic Information

Product Name	Ezetimibe Impurity 71
CAS No.	2191318-99-5
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 71; Ezetimibe EP Impurity I; Ezetimibe USP Impurity; SCH 58235 Impurity; Zetia Impurity; Azetidinone Impurity of Ezetimibe
EINECS	Contact for details

Quality Control

Our Ezetimibe Impurity 71 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, GC, MS, and NMR to confirm identity, purity, and strength. A comprehensive Certificate of Analysis (COA) is provided, detailing all test results against established specifications. Our quality commitment aligns with cGMP principles and relevant ICH guidelines to support your regulatory needs.

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 product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle the container with care to minimize exposure to atmospheric humidity.

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)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%
Assay	97.0% - 103.0% (on anhydrous basis)

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