Fenofibrate Impurity 18 CAS CATO-C4X-101818

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-101818
Molecular FormulaC20H19ClO4
Molecular Weight358.82 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fenofibrate Impurity 18 CAS CATO-C4X-101818 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Fenofibrate Impurity 18.

CATO supplies Fenofibrate Impurity 18 (CAS CATO-C4X-101818), a pharmacopoeial impurity reference standard (molecular formula C20H19ClO4, MW 358.82 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Fenofibrate Impurity 18 (C20H19ClO4) is characterized by a flavonoid core, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

As a certified reference material (CRM), Fenofibrate Impurity 18 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC20H19ClO4
Molecular Weight358.82 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing

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