Description

Ezetimibe Impurity 34 is a designated impurity 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 reference marker 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 reference material (CRM) for the identification and quantification of impurities in Ezetimibe active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure batches of Ezetimibe API meet specified impurity limits as per ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (heat, light, humidity) to establish shelf life.
• Regulatory Submissions: Provides necessary data on impurity characterization for drug master files (DMFs), investigational new drug (IND), and new drug application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Supports process chemistry research to understand and minimize the formation of this impurity during the synthesis of Ezetimibe.

Basic Information

Product Name	Ezetimibe Impurity 34
CAS No.	2280081-69-6
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 Related Compound 34; Ezetimibe EP Impurity I; Ezetimibe USP Impurity; Ezetimibe Process Impurity; (3R,4S)-Ezetimibe Isomer; Azetidinone Impurity of Ezetimibe
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 34 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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.