Description

Ezetimibe Impurity 29 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Ezetimibe during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and analytical laboratories for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Ezetimibe API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in quality control (QC) laboratories.
• Stability Studies and Forced Degradation: Employed to understand the degradation pathways of Ezetimibe and to establish appropriate shelf-life and storage conditions.
• Regulatory Submission and Compliance: Essential for preparing documentation for regulatory agencies (e.g., FDA, EMA) to demonstrate control over the impurity profile as per ICH Q3A/B guidelines.
• Chemical Research and Synthesis: Used by chemists to study the structure-activity relationship (SAR) or to develop synthetic routes for Ezetimibe with improved purity.
• Quality Control and Batch Release Testing: Acts as a system suitability standard and for quantitative analysis during the routine QC testing of Ezetimibe batches.

Basic Information

Product Name	Ezetimibe Impurity 29
CAS No.	1607018-84-7
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 29; Ezetimibe EP Impurity J; Ezetimibe USP Impurity; Zetia Impurity 29; SCH 58235 Impurity; (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone
EINECS	Contact for details

Quality Control

Our Ezetimibe Impurity 29 is manufactured under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (IR, NMR, MS), to ensure identity, purity, and traceability. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing all test results against stringent in-house specifications aligned with pharmacopeial standards. Our quality commitment supports your regulatory needs for pharmaceutical development and compliance.

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. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

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)	Any individual impurity ≤ 0.5% Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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