Digoxin EP Impurity E CAS 52589-12-5

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.52589-12-5
Molecular FormulaC41H64O15
Molecular Weight796.94 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Digoxin EP Impurity E CAS 52589-12-5 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 796.94 g/mol gives Digoxin EP Impurity E distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Digoxin EP Impurity E (CAS 52589-12-5, C41H64O15) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system, Digoxin EP Impurity E is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 796.94 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

As a certified reference material (CRM), Digoxin EP Impurity E meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC41H64O15
Molecular Weight796.94 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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1972

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