Description

Ezetimibe Ring-Opening Dehydrate Impurity is a critical pharmaceutical reference standard used to monitor and control the quality of the active pharmaceutical ingredient (API) Ezetimibe. This specific impurity is essential for ensuring the purity, safety, and efficacy of the final drug product in compliance with stringent global regulatory requirements. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, stability studies, and regulatory submissions.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of the ring-opening dehydrate impurity in Ezetimibe API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch release testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed to monitor impurity formation under various stress conditions (e.g., heat, humidity, light) as part of drug product shelf-life determination.
• Regulatory Compliance & Filings: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for submissions to agencies like the FDA, EMA, and PMDA.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop improved purification processes for Ezetimibe.

Basic Information

Product Name	Ezetimibe Ring-Opening Dehydrate Impurity
CAS No.	1292292-63-7
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 Ring-Opened Dehydrate; Ezetimibe Dehydrate Impurity; Ezetimibe Related Compound; Ezetimibe Degradation Product; Zetia Impurity; SCH 58235 Impurity
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Ring-Opening Dehydrate Impurity is manufactured and analyzed under strict quality management systems. It undergoes rigorous testing to ensure identity, purity, and consistency, meeting the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques such as 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 at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
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% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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