Fenofibrate EP Impurity C CAS 217636-47-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.217636-47-0
Molecular FormulaC17H15ClO3
Molecular Weight302.75 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Fenofibrate EP Impurity C CAS 217636-47-0 chemical structure

Description

As a certified reference material (CRM), Fenofibrate EP Impurity C 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.

As a process- or degradation-related impurity, Fenofibrate EP Impurity C (CAS 217636-47-0, C17H15ClO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Fenofibrate EP Impurity C (C17H15ClO3) contains a steroid 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. 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.

Physical & Chemical Properties

Molecular FormulaC17H15ClO3
Molecular Weight302.75 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.)2019
Halogen ContentCl-containing

Related Fenofibrate Standards

Recommended Standards

Why CATO?