Digoxin EP Impurity K CAS 31539-05-6

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.31539-05-6
Molecular FormulaC47H74O17
Molecular Weight911.08 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Digoxin EP Impurity K CAS 31539-05-6 chemical structure

Description

The molecular framework of Digoxin EP Impurity K (C47H74O17) 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 the polarity and ionization state of its functional groups, 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).

Digoxin EP Impurity K (CAS 31539-05-6) is a certified pharmaceutical impurity reference standard with the molecular formula C47H74O17 and a molecular weight of 911.08 g/mol.

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

Molecular FormulaC47H74O17
Molecular Weight911.08 g/mol
Purity>90%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1966

Related Digoxin Standards

Recommended Standards

Why CATO?