Maxacalcitol Impurity 14 CAS 496046-06-1

Description

The occurrence of Maxacalcitol Impurity 14 is closely related to a phosphonate group, a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Maxacalcitol Impurity 14 (CAS 496046-06-1) is a certified pharmaceutical impurity reference standard with the molecular formula C33H51O3PSi2 and a molecular weight of 582.90 g/mol.

Maxacalcitol Impurity 14 (C33H51O3PSi2) contains a phosphonate group, a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. 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 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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