Description

Ezetimibe Impurity 80 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the cholesterol-lowering drug Ezetimibe during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments. The material is essential for method validation, impurity profiling, and stability studies to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the qualitative and quantitative analysis of Ezetimibe active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (HPLC, UPLC) for impurity detection and quantification.
• Quality Control & Assurance: Employed in routine batch release testing to monitor and control the level of this specific impurity, ensuring it remains within acceptable limits (ICH guidelines).
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require complete impurity identification and characterization data.
• Stability Studies: Used as a marker to track the formation or increase of this impurity in Ezetimibe drug products under various stress and long-term storage conditions.
• Research on Degradation Pathways: Aids in studying the chemical degradation mechanisms of Ezetimibe, helping to improve formulation stability.

Basic Information

Product Name	Ezetimibe Impurity 80
CAS No.	1683564-75-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ezetimibe Related Compound 80; Ezetimibe EP Impurity I; Ezetimibe USP Impurity; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; UNII-9F6T171B4P; Ezetimibe Impurity (EP Impurity I); Ezetimibe Specified Impurity
EINECS	Contact for details

Quality Control

Our Ezetimibe Impurity 80 is manufactured and tested under strict quality systems. Each batch is characterized using advanced analytical techniques including HPLC, GC, MS, and NMR to confirm identity and purity, ensuring compliance with relevant pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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