Dronedarone Impurity 38 CAS CATO-C4X-109238

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-109238
Molecular FormulaC30H42N2O4
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dronedarone Impurity 38 CAS CATO-C4X-109238 chemical structure

Description

As a certified reference material (CRM), Dronedarone Impurity 38 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.

CATO supplies Dronedarone Impurity 38 (CAS CATO-C4X-109238), a pharmacopoeial impurity reference standard (molecular formula C30H42N2O4HCl, MW 531.13 g/mol) used for the identification and quantification of trace impurities in APIs.

Dronedarone Impurity 38 (C30H42N2O4HCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

Physical & Chemical Properties

Molecular FormulaC30H42N2O4 HCl
Molecular Weight531.13 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms2

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