Flecainide EP Impurity F CAS CATO-C4X-25463

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-25463
Molecular FormulaC18H22F6N2O3
Molecular Weight428.37 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Flecainide EP Impurity F CAS CATO-C4X-25463 chemical structure

Description

As a certified reference material (CRM), Flecainide EP Impurity F 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.

CATO supplies Flecainide EP Impurity F (CAS CATO-C4X-25463), a pharmacopoeial impurity reference standard (molecular formula C18H22F6N2O3, MW 428.37 g/mol) used for the identification and quantification of trace impurities in APIs.

Flecainide EP Impurity F (C18H22F6N2O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC18H22F6N2O3
Molecular Weight428.37 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms2

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