Phytomenadione/Vitamin K1 Impurity 108 CAS CATO-C4X-2207108

Description

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.

Phytomenadione/Vitamin K1 Impurity 108 (CAS CATO-C4X-2207108) is a certified pharmaceutical impurity reference standard with the molecular formula C20H40O and a molecular weight of 296.53 g/mol.

Structurally, Phytomenadione/Vitamin K1 Impurity 108 (C20H40O) contains a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 1.0, corresponding to approximately 1 ring(s) or double-bond equivalent(s). With a molecular weight of 296.53 g/mol, it falls into the medium-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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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