Description

Ezetimibe Impurity 43 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the cholesterol-lowering drug Ezetimibe by serving as a known impurity during analytical method development and validation. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control, stability studies, and compliance with stringent pharmacopeial guidelines.

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: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): A critical component in routine batch release testing to ensure drug substance and product purity meets ICH, USP, or EP specifications.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2) guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used by R&D chemists to understand and optimize synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Ezetimibe Impurity 43
CAS No.	1621715-63-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ezetimibe Related Compound 43; Ezetimibe EP Impurity C; Ezetimibe USP Impurity; (3R,4S)-1-(4-Fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one; UNII-7V5R5U8Q7M; Ezetimibe Impurity C (EP); Ezetimibe Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Impurity 43 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards (USP, EP, ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and traceability data.

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 desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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