Description

Ezetimibe Impurity 79 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the identification, quantification, and control of process-related impurities during the manufacture of the cholesterol-lowering drug Ezetimibe. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, ensuring drug safety and compliance with stringent regulatory guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for analytical method development and validation.
• Impurity Profiling: Identification and quantification of this specific impurity in Ezetimibe Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Quality Control & Assurance: Used in-house by API manufacturers to monitor and control impurity levels against ICH Q3A/B guidelines.
• Regulatory Submissions: Serves as a critical component in regulatory filings (e.g., for FDA, EMA) to establish impurity limits and control strategies.
• Stability Studies: Employed to track the formation of degradation impurities in Ezetimibe under various stress conditions.
• Method Transfer: Acts as a system suitability test compound when transferring analytical methods between laboratories or sites.

Basic Information

Product Name	Ezetimibe Impurity 79
CAS No.	795306-57-9
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 79; Ezetimibe EP Impurity I; Ezetimibe USP Impurity; Zetia Impurity 79; 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 79 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards (USP/EP/ICH). 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 controlled room temperature (15-25°C). This material 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 powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.