tert-butyl (R)-(2,5-dimethyl-4-(1-methyl-1,2,3,6-tetrahydropyridin-4-yl)-2,3-dihydrobenzofuran-7-yl)carbamate CAS CATO-C4X-30133

Description

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.

CATO supplies tert-butyl (R)-(2,5-dimethyl-4-(1-methyl-1,2,3,6-tetrahydropyridin-4-yl)-2,3-dihydrobenzofuran-7-yl)carbamate (CAS CATO-C4X-30133), a pharmacopoeial impurity reference standard (molecular formula C21H30N2O3, MW 358.47 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of tert-butyl (R)-(2,5-dimethyl-4-(1-methyl-1,2,3,6-tetrahydropyridin-4-yl)-2,3-dihydrobenzofuran-7-yl)carbamate (C21H30N2O3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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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