Description

Ezetimibe Impurity 78 is a designated impurity standard used in the analytical profiling and quality control of the cholesterol-lowering pharmaceutical agent, Ezetimibe. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Ezetimibe Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release: Essential for routine quality control testing to ensure API and drug product batches meet stringent pharmacopeial (e.g., USP, EP) and ICH regulatory specifications for impurity limits.
• Stability Studies: Employed to monitor the formation of this specific impurity during forced degradation and long-term stability studies of Ezetimibe formulations.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) to support drug approval processes.
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to develop purification processes for the Ezetimibe API.

Basic Information

Item	Details
Product Name	Ezetimibe Impurity 78
CAS No.	942485-60-1
Molecular Formula	C24H21F2NO3
Molecular Weight	409.43 g/mol
Synonyms	(3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; Ezetimibe EP Impurity J; Ezetimibe Related Compound J; Ezetimibe Impurity J; (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 78 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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