Description

Ezetimibe Diol Impurity CAS NO 1374250-08-4 is a high-purity chemical reference standard, specifically a diol derivative impurity of the cholesterol-lowering drug Ezetimibe. This compound is critical for pharmaceutical research and development, serving as a key marker for method development, validation, and quality control in API manufacturing. It is primarily required by analytical laboratories, quality assurance departments, and R&D teams within the global pharmaceutical and biotechnology sectors to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of process-related impurities in Ezetimibe Active Pharmaceutical Ingredient (API).
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods for impurity detection.
• Quality Control & Assurance: Essential for routine batch testing in API manufacturing to monitor and control impurity levels against ICH guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Employed as a reference in forced degradation and shelf-life studies to track impurity formation over time.
• Chemical Research: Used in academic and industrial research to study the synthesis pathways and degradation chemistry of Ezetimibe.

Basic Information

Product Name	Ezetimibe Diol Impurity
CAS No.	1374250-08-4
Molecular Formula	C24H21F2NO4
Molecular Weight	425.43 g/mol
Synonyms	(3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; Ezetimibe Dihydroxy Impurity; Ezetimibe Impurity D; Ezetimibe Related Compound D; (3R,4S)-3-[(3S)-3-(4-Fluorophenyl)-3-hydroxypropyl]-1-(4-fluorophenyl)-4-(4-hydroxyphenyl)azetidin-2-one; Zetia Diol Impurity; SCH 58235 Diol Impurity
EINECS	Contact for details

Quality Control

Our Ezetimibe Diol Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, ensuring traceability and compliance with current pharmacopeial standards and ICH Q3A/B guidelines for impurities in new drug substances.

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 should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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