Finasteride EP Impurity A CAS 98319-24-5

Description

Compared with other compounds in its class, the molecular weight of 374.56 g/mol gives Finasteride EP Impurity A distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Finasteride EP Impurity A (CAS 98319-24-5), a pharmacopoeial impurity reference standard (molecular formula C23H38N2O2, MW 374.56 g/mol) used for the identification and quantification of trace impurities in APIs.

Finasteride EP Impurity A (C23H38N2O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, 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 high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

As a certified reference material (CRM), Finasteride 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.

Physical & Chemical Properties

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