Fenofibrate EP Impurity E CAS 42019-07-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.42019-07-8
Molecular FormulaC18H17ClO4
Molecular Weight332.78 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fenofibrate EP Impurity E CAS 42019-07-8 chemical structure

Description

The occurrence of Fenofibrate EP Impurity E is closely related to a flavonoid core, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Fenofibrate EP Impurity E (CAS 42019-07-8) is a certified pharmaceutical impurity reference standard with the molecular formula C18H17ClO4 and a molecular weight of 332.78 g/mol.

Fenofibrate EP Impurity E (C18H17ClO4) contains a flavonoid core, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

CATO manufactures Fenofibrate EP Impurity E under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC18H17ClO4
Molecular Weight332.78 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1969
Halogen ContentCl-containing

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