Description

Ezetimibe Impurity 33 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 active pharmaceutical ingredient (API) 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 batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ezetimibe API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control & Batch Release: A critical component in the quality control process to ensure batches of Ezetimibe comply with stringent pharmacopeial (e.g., USP, EP) and ICH guidelines.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions to establish product shelf life.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization and control data.
• Research & Development: Used in synthetic chemistry research to understand and control impurity formation during the manufacturing process of Ezetimibe.

Basic Information

Product Name	Ezetimibe Impurity 33
CAS No.	1829558-53-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ezetimibe Related Compound 33; Ezetimibe EP Impurity J; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; UNII-9K8J0V8E9I; Ezetimibe Impurity J; Ezetimibe Isomer; Ezetimibe Diastereomer; Zetia Impurity 33
EINECS	Contact for details

Quality Control

Our Ezetimibe Impurity 33 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
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 guidelines

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