Description

Ezetimibe Azetidinone Ring-Opened Impurity is a critical pharmaceutical reference standard used in the quality control and analytical development of the cholesterol-lowering drug Ezetimibe. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) by serving as a known impurity for method validation and stability studies. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Ezetimibe API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling and identification.
• Stability Indicating Method: Employed in forced degradation studies to monitor the formation of this specific degradation product under various stress conditions.
• Quality Control & Batch Release Testing: Critical for setting impurity specifications and ensuring batch-to-batch consistency of Ezetimibe in compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop improved synthetic routes with lower impurity levels.

Basic Information

Product Name	Ezetimibe Azetidinone Ring-Opened Impurity
CAS No.	1391053-63-6
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 Azetidinone Ring-Opened Degradant; Ezetimibe Impurity (Azetidinone Ring-Opened); Ezetimibe Related Compound; (3R,4S)-3-[(3S)-3-(4-Fluorophenyl)-3-hydroxypropyl]-1-(4-fluorophenyl)-4-(4-hydroxyphenyl)azetidin-2-one
EINECS	Contact for details

Quality Control

Our Ezetimibe Azetidinone Ring-Opened Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is characterized and qualified using advanced techniques including HPLC, LC-MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A/B and pharmacopeial guidelines.

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 under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere to minimize oxidation.

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 single 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.