Description

Ezetimibe Benzyl Diol Impurity is a key process-related impurity and analytical reference standard used in the pharmaceutical development and manufacturing of Ezetimibe. This compound is critical for ensuring the purity, safety, and regulatory compliance of the final active pharmaceutical ingredient (API). It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and manufacturers for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of the benzyl diol impurity in Ezetimibe API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity detection in compliance with ICH Q2(R1) and Q3A(R2) guidelines.
• Quality Control & Batch Release Testing: Essential for routine QC testing to monitor and control impurity levels during API synthesis and ensure batch-to-batch consistency.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation and establish shelf-life specifications.
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Common Technical Documents (CTD), and submissions to agencies like the FDA and EMA.
• Process Chemistry Research: Used by chemists to study reaction pathways, optimize synthesis routes, and minimize the formation of this specific impurity.

Basic Information

Product Name	Ezetimibe Benzyl Diol Impurity
CAS No.	1374250-06-2
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 Benzyl Diol Related Compound; Ezetimibe Impurity (Benzyl Diol); Ezetimibe EP Impurity D; Ezetimibe USP Related Compound D; (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone; Zetia Impurity (Benzyl Diol).
EINECS	Contact for details

Quality Control

Our Ezetimibe Benzyl Diol Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical analysis. Each batch is characterized and released with a comprehensive Certificate of Analysis (COA) that includes data from HPLC purity, related substances, NMR, and MS. We support compliance with ICH, USP, and EP guidelines. COAs are available upon request and can be tailored to meet specific customer or regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. The material is hygroscopic (moisture-sensitive); ensure containers are sealed tightly after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
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 single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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