Description

Ezetimibe Impurity 82 is a high-purity chemical reference standard used in pharmaceutical research, development, and quality control. This compound is critical for ensuring the safety and efficacy of the cholesterol-lowering drug Ezetimibe by enabling accurate identification and quantification of related substances. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in method validation and impurity profiling. The availability of this well-characterized impurity supports compliance with stringent pharmacopeial guidelines for drug substance and product specifications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Ezetimibe.
• Impurity Profiling: Essential for identifying and quantifying this specific impurity in Ezetimibe Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development and Validation: Serves as a critical component in developing and validating analytical methods, such as HPLC and LC-MS, for impurity detection.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure impurity levels remain within specified limits.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions to establish product shelf life.

Basic Information

Product Name	Ezetimibe Impurity 82
CAS No.	1416263-36-9
Molecular Formula	C24H21F2NO3
Molecular Weight	409.43 g/mol
Synonyms	Ezetimibe Related Compound 82; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; UNII-7F5C3I3X4K; 7F5C3I3X4K; Ezetimibe EP Impurity H; Ezetimibe Impurity 82 (EP H); Ezetimibe Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 82 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identity confirmation by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. Our quality standards align with the requirements of major pharmacopeias (USP, EP) to support your regulatory and research needs.

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 degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
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% w/w

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