Dapoxetine Impurity 102 CAS 119356-77-3

Description

The occurrence of Dapoxetine Impurity 102 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Dapoxetine Impurity 102 (CAS 119356-77-3), a pharmacopoeial impurity reference standard (molecular formula C21H23NO, MW 305.41 g/mol) used for the identification and quantification of trace impurities in APIs.

Dapoxetine Impurity 102 (C21H23NO) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility; 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.

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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