Dronedarone EP Impurity C(Dronedarone USP RC B)Oxalate CAS 141626-57-5(Free Base)

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.141626-57-5(Free Base)
Molecular FormulaC32H46N2O7S2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dronedarone EP Impurity C(Dronedarone USP RC B)Oxalate CAS 141626-57-5(Free Base) chemical structure

Description

Compared with other compounds in its class, the molecular weight of 724.88 g/mol gives Dronedarone EP Impurity C(Dronedarone USP RC B)Oxalate distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Dronedarone EP Impurity C(Dronedarone USP RC B)Oxalate (CAS 141626-57-5(Free Base)) is a certified pharmaceutical impurity reference standard with the molecular formula C32H46N2O7S2C2H2O4 and a molecular weight of 724.88 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a sulfone group, a hydroxyl group, an ether linkage, Dronedarone EP Impurity C(Dronedarone USP RC B)Oxalate is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 724.88 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

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 FormulaC32H46N2O7S2 C2H2O4
Molecular Weight724.88 g/mol
Purity>95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2
Sulfur Atoms2

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