Digoxin EP Impurity J CAS 5355-48-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.5355-48-6
Molecular FormulaC43H66O15
Molecular Weight822.98 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Digoxin EP Impurity J CAS 5355-48-6 chemical structure

Description

Digoxin EP Impurity J (CAS 5355-48-6) is a certified pharmaceutical impurity reference standard with the molecular formula C43H66O15 and a molecular weight of 822.98 g/mol.

The molecular framework of Digoxin EP Impurity J (C43H66O15) 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

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 FormulaC43H66O15
Molecular Weight822.98 g/mol
Purity>95%
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.)1958

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