Description

Ezetimibe Impurity 38 is a high-purity 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 laboratories, quality assurance departments, and research institutions focused on pharmaceutical impurity profiling and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Analytical Method Development: Used in the development and validation of HPLC, UPLC, and LC-MS methods for impurity detection and separation.
• Quality Control & Assurance: Serves as a system suitability standard and for quantifying Ezetimibe Impurity 38 in active pharmaceutical ingredient (API) and finished drug product batches.
• Regulatory Compliance & Filing: Provides essential data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and control strategies.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Facilitates studies on the synthesis pathway, degradation mechanisms, and toxicological profile of Ezetimibe-related substances.

Basic Information

Product Name	Ezetimibe Impurity 38
CAS No.	1701462-59-0
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 38; Ezetimibe EP Impurity H; Ezetimibe USP Related Compound; Zetia Impurity 38
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 38 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. 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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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