Description

(4-Chlorophenyl)[4-(1-Methylethoxy)Phenyl]Methanone (Fenofibrate Impurity) is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of the active pharmaceutical ingredient, Fenofibrate, ensuring drug safety and efficacy. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Fenofibrate drug substance and finished dosage forms.
• Analytical Method Development & Validation: Used to develop and validate sensitive HPLC, UPLC, and GC methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring product consistency and regulatory compliance.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Fenofibrate.
• Pharmacopoeial Testing: Supports testing procedures aligned with USP, EP, and other international pharmacopoeia monographs for Fenofibrate.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Synthesis: Used as an intermediate or starting material in synthetic chemistry research for developing novel analogs or studying metabolic pathways.

Basic Information

Product Name	(4-Chlorophenyl)[4-(1-Methylethoxy)Phenyl]Methanone (Fenofibrate Impurity)
CAS No.	154356-96-4
Molecular Formula	C16H15ClO2
Molecular Weight	274.74 g/mol
Synonyms	4'-Chloro-4-isopropoxybenzophenone; 1-(4-Chlorophenyl)-1-[4-(1-methylethoxy)phenyl]methanone; Fenofibrate Related Compound; Fenofibrate Impurity; Benzophenone, 4'-chloro-4-(1-methylethoxy)-; 4-Chloro-4'-isopropoxybenzophenone; Isopropyl 4-(4-chlorobenzoyl)phenyl ether
EINECS	Contact for details

Quality Control

Our (4-Chlorophenyl)[4-(1-Methylethoxy)Phenyl]Methanone is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide comprehensive Certificates of Analysis (COA) with detailed chromatograms and spectral data, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and ICH guidelines for pharmaceutical impurities.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
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 ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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