Phytomenadione Impurity 28 CAS 107759-10-4

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.107759-10-4
Molecular FormulaC31H48O4
Molecular Weight484.71 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Phytomenadione Impurity 28 CAS 107759-10-4 chemical structure

Description

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.

Phytomenadione Impurity 28 (CAS 107759-10-4) is a certified pharmaceutical impurity reference standard with the molecular formula C31H48O4 and a molecular weight of 484.71 g/mol.

The molecular framework of Phytomenadione Impurity 28 (C31H48O4) is characterized by a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

Physical & Chemical Properties

Molecular FormulaC31H48O4
Molecular Weight484.71 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>90%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1987

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