Description

Ezetimibe Dehydoxy Impurity is a specified impurity and 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 active pharmaceutical ingredient (API) by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Ezetimibe API and finished dosage forms.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, calibrating, and validating chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure API and drug products meet ICH, USP, or EP impurity limits.
• Stability Studies: Used to track the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control.
• Research & Development (R&D): Utilized in synthetic chemistry research to study the degradation pathways and metabolism of Ezetimibe.

Basic Information

Product Name	Ezetimibe Dehydoxy Impurity
CAS No.	204589-58-2
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 Dehydroxy Impurity; Ezetimibe EP Impurity D; Ezetimibe Related Compound D; Ezetimibe Deshydroxy Impurity; Ezetimibe Impurity D; (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone
EINECS	Contact for details

Quality Control

Our Ezetimibe Dehydoxy 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 released with a comprehensive Certificate of Analysis (COA) providing data on identity, purity (by HPLC), and impurity profile. We support compliance with ICH Q3A/B, USP, and European Pharmacopoeia guidelines. COAs are available upon request.

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); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
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.