Description

Ezetimibe Impurity 81 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 safety, efficacy, and regulatory compliance of the final drug product by serving as a reference marker for identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, method validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Ezetimibe active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Quality Control & Batch Release: Employed in routine QC testing to ensure Ezetimibe batches meet stringent pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of Ezetimibe.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Process Chemistry: Aids in understanding the synthesis pathway of Ezetimibe and helps in optimizing manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Ezetimibe Impurity 81
CAS No.	1197343-09-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ezetimibe Related Compound 81; 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-7V3K1T5F6I; Ezetimibe Impurity I (EP); Ezetimibe Process Impurity
EINECS	Contact for details

Quality Control

Our Ezetimibe Impurity 81 is manufactured and handled 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 impurity standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Meets internal specifications
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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