Amorolfine impurity 71 CAS CATO-C4X-154271

Description

Compared with other compounds in its class, the molecular weight of 369.97 g/mol gives Amorolfine impurity 71 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Amorolfine impurity 71 (CAS CATO-C4X-154271), a pharmacopoeial impurity reference standard (molecular formula C21H35NO2HCl, MW 369.97 g/mol) used for the identification and quantification of trace impurities in APIs.

Amorolfine impurity 71 (C21H35NO2HCl) contains a steroid core, an amide group, 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

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