Dutasteride EP Impurity B CAS 2512195-98-9

Description

Compared with other compounds in its class, the molecular weight of 344.49 g/mol gives Dutasteride EP Impurity B distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Dutasteride EP Impurity B (CAS 2512195-98-9), a pharmacopoeial impurity reference standard (molecular formula C21H32N2O2, MW 344.49 g/mol) used for the identification and quantification of trace impurities in APIs.

Dutasteride EP Impurity B (C21H32N2O2) 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 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.

As a certified reference material (CRM), Dutasteride EP Impurity B 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

Why CATO?

• ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
• 130,000+ catalog items in stock, COA supplied with every batch
• Worldwide shipping with full export documentation (HS code guidance available)
• Technical support: +86 18665070610 / Nicole.chen@cato-chem.com