Description

3-[4-(4-Chlorobenzoyl)Phenoxy]-2-Butanone (Fenofibrate Impurity) is a high-purity chemical reference standard critical for pharmaceutical research, development, and quality control. This compound serves as a key impurity marker for the lipid-regulating drug Fenofibrate, enabling precise analytical method development and validation. It is essential for laboratories in the pharmaceutical and fine chemical industries focused on ensuring drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Fenofibrate Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods to monitor impurity levels throughout the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Integral for routine batch testing in pharmaceutical QC laboratories to ensure Fenofibrate products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Employed as a marker to track degradation pathways and assess the stability of Fenofibrate under various storage conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Utilized in synthetic chemistry R&D to study metabolic pathways, degradation mechanisms, and to synthesize related compounds for biological evaluation.

Basic Information

Product Name	3-[4-(4-Chlorobenzoyl)Phenoxy]-2-Butanone (Fenofibrate Impurity)
CAS No.	217636-47-0
Molecular Formula	C17H15ClO3
Molecular Weight	302.75 g/mol
Synonyms	Fenofibrate Related Compound; 1-[4-(4-Chlorobenzoyl)phenoxy]-3-butanone; 4'-Chloro-4-butyryloxybenzophenone; 2-Butanone, 3-[4-(4-chlorobenzoyl)phenoxy]-; Fenofibrate Impurity A (in some references); 4-(4-Chlorobenzoyl)phenyl 3-oxobutyl ether
EINECS	Contact for details

Quality Control

Every batch of 3-[4-(4-Chlorobenzoyl)Phenoxy]-2-Butanone is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC-MS, NMR) to ensure compliance with pharmacopeial standards and customer-specific requirements. 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 at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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