Description

Ezetimibe Impurity 54 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of specific impurities during the development and manufacturing of the cholesterol-lowering drug Ezetimibe. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D, API manufacturing, and regulatory compliance laboratories to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for calibrating analytical instruments and validating testing methods.
• Method Development and Validation: Crucial for developing and validating HPLC, UPLC, and LC-MS methods for impurity profiling of Ezetimibe.
• Quality Control & Assurance (QC/QA): Used in routine batch testing of Ezetimibe Active Pharmaceutical Ingredient (API) and finished dosage forms to ensure impurity levels are within specified limits (ICH guidelines).
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions and over shelf-life.
• Research and Development: Facilitates studies on impurity formation pathways, degradation chemistry, and process optimization in synthetic routes for Ezetimibe.

Basic Information

Product Name	Ezetimibe Impurity 54
CAS No.	1185883-39-9
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 54; Ezetimibe EP Impurity I; Ezetimibe USP Impurity; Zetia Impurity 54; SCH 58235 Impurity; (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 54 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards (USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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