Phytomenadione/Vitamin K1 Impurity 113 CAS CATO-C4X-2207113

Description

The occurrence of Phytomenadione/Vitamin K1 Impurity 113 is closely related to a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Phytomenadione/Vitamin K1 Impurity 113 (CAS CATO-C4X-2207113), a pharmacopoeial impurity reference standard (molecular formula C20H40O, MW 296.53 g/mol) used for the identification and quantification of trace impurities in APIs.

Phytomenadione/Vitamin K1 Impurity 113 (C20H40O) contains 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 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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