Description

Ezetimibe Azetidinone Ring Opened Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of the cholesterol-lowering drug Ezetimibe. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a marker for a specific degradation pathway. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling. The compound is supplied with full analytical characterization to support rigorous quality assurance protocols.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of the azetidinone ring-opened degradant in Ezetimibe Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity levels throughout the drug's shelf life.
• Stability Studies & Forced Degradation: Employed in stress testing (hydrolytic, oxidative, photolytic) to understand the degradation behavior of Ezetimibe and establish appropriate storage conditions.
• Quality Control & Batch Release: A critical component in the QC testing of Ezetimibe batches to ensure compliance with stringent pharmacopeial limits (e.g., USP, EP, ICH Q3A/B) for unknown and specified impurities.
• Regulatory Submissions: Provides necessary data and a characterized sample for inclusion in Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry research to study the degradation mechanism and to develop more stable formulations of Ezetimibe.

Basic Information

Product Name	Ezetimibe Azetidinone Ring Opened Impurity
CAS No.	1618657-29-6
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 Ring-Opened Form; Ezetimibe Azetidinone Hydrolyzed Impurity; Ezetimibe Degradant; Ezetimibe Ring-Opened Degradation Product; Ezetimibe Related Compound; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one Hydrolysis Product
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Azetidinone Ring Opened Impurity is manufactured and analyzed under strict quality systems. The material undergoes comprehensive testing including identification (IR, NMR), purity assay (HPLC), and control of related substances and residual solvents to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results, methods, and specifications is provided with each shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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