Description

Ezetimibe Impurity 1 is a specified impurity and a key reference standard used in the analytical profiling of the cholesterol-lowering pharmaceutical agent, Ezetimibe. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) during development and manufacturing. It is primarily required by pharmaceutical companies, analytical laboratories, and regulatory bodies for quality control, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Ezetimibe API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, calibrate, and validate High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH).
• Stability Studies: Employed to track the formation of degradation products in Ezetimibe formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to synthesize purer batches of the API.

Basic Information

Product Name	Ezetimibe Impurity 1
CAS No.	190595-66-5
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 A; Ezetimibe EP Impurity A; Ezetimibe USP Impurity A; (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone; Zetia Impurity 1; SCH 58235 Impurity
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards (USP/EP/ICH) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including HPLC purity, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from 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)	Total impurities ≤ 2.0% Any individual 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.