Description

Ezetimibe Impurity 76 is a high-purity reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and manufacturing of the cholesterol-lowering drug Ezetimibe. It is essential for laboratories and manufacturers requiring precise impurity profiling and method validation. This product supports compliance with stringent regulatory standards for drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Ezetimibe API and finished dosage forms.
• Analytical Method Development: Used to develop, validate, and calibrate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Assurance & Control (QA/QC): Critical for routine batch testing in pharmaceutical manufacturing to ensure impurity levels remain within ICH guidelines.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed in forced degradation and long-term stability studies of Ezetimibe to monitor impurity formation over time.
• Research & Development: Used in synthetic chemistry research to study the formation pathways and properties of this specific impurity.

Basic Information

Product Name	Ezetimibe Impurity 76
CAS No.	1185883-46-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ezetimibe Related Compound 76; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; UNII-7Q6J4J8Q4F; Ezetimibe EP Impurity G; Ezetimibe Impurity 7; Ezetimibe Impurity G; Ezetimibe Specified Impurity G
EINECS	Contact for details

Quality Control

Our Ezetimibe Impurity 76 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality protocols are designed to support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed and stored in a desiccator or under conditions of low humidity to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%

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