Drospirenone Impurity N1 CAS 82543-15-5

Description

Compared with other compounds in its class, the molecular weight of 316.43 g/mol gives Drospirenone Impurity N1 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Drospirenone Impurity N1 (CAS 82543-15-5) is a certified pharmaceutical impurity reference standard with the molecular formula C20H28O3 and a molecular weight of 316.43 g/mol.

Drospirenone Impurity N1 (C20H28O3) contains a steroid core, 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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