Description

Ezetimibe Impurity 70 is a high-purity chemical reference standard used in pharmaceutical research and development. 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 an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry. The product is supplied with comprehensive analytical data to support regulatory filings and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Ezetimibe Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, used in stability studies and release testing.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity levels against International Council for Harmonisation (ICH) guidelines, ensuring batch-to-batch consistency.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed as a benchmark to track the formation of degradation products under various stress conditions (heat, light, humidity).
• Research & Process Chemistry: Aids in understanding the synthesis pathway of Ezetimibe and optimizing manufacturing processes to minimize this specific impurity.

Basic Information

Item	Details
Product Name	Ezetimibe Impurity 70
CAS No.	795306-53-5
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 70; Ezetimibe EP Impurity I; Ezetimibe USP Impurity; Zetia Impurity; SCH 58235 Impurity; (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 70 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, NMR, and MS. Our quality commitment aligns with cGMP principles 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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

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 unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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