Propafenone EP Impurity A CAS 3516-95-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.3516-95-8
Molecular FormulaC15H14O2
Molecular Weight226.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Propafenone EP Impurity A CAS 3516-95-8 chemical structure

Description

As a certified reference material (CRM), Propafenone EP Impurity A 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, Propafenone EP Impurity A (CAS 3516-95-8, C15H14O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Propafenone EP Impurity A (C15H14O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. 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 FormulaC15H14O2
Molecular Weight226.27 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1958

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