Description

Ezetimibe Impurity 93 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of process-related impurities during the development and manufacturing of the cholesterol-lowering drug Ezetimibe. It is an essential material for analytical chemists, quality assurance professionals, and R&D scientists working in pharmaceutical development, regulatory compliance, and contract research organizations (CROs).

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying this specific impurity in Ezetimibe active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate stability-indicating HPLC, UPLC, or LC-MS methods for Ezetimibe.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to ensure Ezetimibe batches meet stringent pharmacopeial (e.g., USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Acts as a marker to track the formation or degradation of this impurity under various stress conditions (thermal, photolytic, hydrolytic) as per ICH Q1A(R2) requirements.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CMC sections) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Used in synthetic chemistry research to study the formation pathway of this impurity and develop purer manufacturing processes.

Basic Information

Product Name	Ezetimibe Impurity 93
CAS No.	1478663-99-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ezetimibe Related Compound 93; Ezetimibe EP Impurity J; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; UNII-9K5I0C6W8P; Ezetimibe Impurity 9; Ezetimibe Process Impurity
EINECS	Contact for details

Quality Control

Our Ezetimibe Impurity 93 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and methods. Our quality commitment aligns with cGMP principles for pharmaceutical impurities.

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 product is hygroscopic (moisture-sensitive) and must be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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