Description

Ezetimibe Related Impurity 37 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the cholesterol-lowering drug Ezetimibe. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Ezetimibe Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in routine quality control testing to ensure Ezetimibe batches meet pharmacopeial (USP, EP) and ICH guidelines for impurity limits.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive characterization data for specified impurities as per FDA and EMA requirements.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to determine drug shelf-life.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Ezetimibe, aiding in process optimization.

Basic Information

Item	Detail
Product Name	Ezetimibe Related Impurity 37
CAS No.	204589-68-4
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 Impurity 37; Ezetimibe EP Impurity G; (3R,4S)-1-(p-Fluorophenyl)-3-[(3S)-3-(p-fluorophenyl)-3-hydroxypropyl]-4-(p-hydroxyphenyl)-2-azetidinone; UNII-5V8C6T5Q4R; AZ9; Ezetimibe Related Compound G
EINECS	Contact for details

Quality Control

Every batch of Ezetimibe Related Impurity 37 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against predefined specifications. Our quality standards align with ICH Q3A/B guidelines for impurities in new drug substances.

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 compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.