Dronedarone Impurity 94 CAS CATO-C4X-109294

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-109294
Molecular FormulaC19H16N2O7
Molecular Weight384.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dronedarone Impurity 94 CAS CATO-C4X-109294 chemical structure

Description

The occurrence of Dronedarone Impurity 94 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Dronedarone Impurity 94 (CAS CATO-C4X-109294), a pharmacopoeial impurity reference standard (molecular formula C19H16N2O7, MW 384.34 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Dronedarone Impurity 94 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 384.34 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.

CATO manufactures Dronedarone Impurity 94 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC19H16N2O7
Molecular Weight384.34 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

Related Dronedarone Standards

Recommended Standards

Why CATO?