Fenofibrate Impurity N1 CAS 55270-71-8

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.55270-71-8
Molecular FormulaC13H9ClO2
Molecular Weight232.66 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fenofibrate Impurity N1 CAS 55270-71-8 chemical structure

Description

The occurrence of Fenofibrate Impurity N1 is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

As a process- or degradation-related impurity, Fenofibrate Impurity N1 (CAS 55270-71-8, C13H9ClO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Fenofibrate Impurity N1 (C13H9ClO2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system. 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. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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 Impurity N1 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 FormulaC13H9ClO2
Molecular Weight232.66 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1972
Halogen ContentCl-containing

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