Phytomenadione/Vitamin K1 Impurity 91 CAS CATO-C4X-220791

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Phytomenadione/Vitamin K1 Impurity 91.

Phytomenadione/Vitamin K1 Impurity 91 (CAS CATO-C4X-220791) is a certified pharmaceutical impurity reference standard with the molecular formula C31H46O2 and a molecular weight of 450.70 g/mol.

Structurally, Phytomenadione/Vitamin K1 Impurity 91 (C31H46O2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 450.70 g/mol, it falls into the moderately-high-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.

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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