Dronedarone Impurity 3 CAS 141645-16-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.141645-16-1
Molecular FormulaC19H17NO5
Molecular Weight339.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dronedarone Impurity 3 CAS 141645-16-1 chemical structure

Description

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.

Dronedarone Impurity 3 (CAS 141645-16-1) is a certified pharmaceutical impurity reference standard with the molecular formula C19H17NO5 and a molecular weight of 339.34 g/mol.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Dronedarone Impurity 3 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 339.34 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).

As a certified reference material (CRM), Dronedarone Impurity 3 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 FormulaC19H17NO5
Molecular Weight339.34 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, 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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1997
Nitrogen Atoms1

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