Description

Ezetimibe Impurity 84 is a high-purity reference standard of a specified impurity associated with the cholesterol-lowering drug Ezetimibe. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing and research. It is primarily used by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) to ensure drug safety, efficacy, and regulatory compliance.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Ezetimibe Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in pharmaceutical research and quality control laboratories.
• Used in stability studies and forced degradation studies to monitor impurity profiles and ensure drug product shelf-life.
• Critical for regulatory compliance and filing, supporting applications to agencies like the FDA, EMA, and PMDA by providing necessary impurity data.
• Serves as a key material in pharmacopoeial testing to meet standards set by USP, EP, or other international pharmacopoeias.
• Utilized by contract manufacturing organizations (CMOs) and API manufacturers for in-process control and batch release testing.

Basic Information

Product Name	Ezetimibe Impurity 84
CAS No.	190595-64-3
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 Related Compound 84; Ezetimibe EP Impurity H; Ezetimibe USP Impurity; Ezetimibe Process Impurity; Zetia Impurity 84
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 84 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopoeial standards (USP/EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

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

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