Lidocaine Impurity 79 CAS CATO-C4X-167979

Description

The occurrence of Lidocaine Impurity 79 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.

Lidocaine Impurity 79 (CAS CATO-C4X-167979) is a certified pharmaceutical impurity reference standard with the molecular formula C17H25NO2 and a molecular weight of 275.39 g/mol.

Lidocaine Impurity 79 (C17H25NO2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. 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.

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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