Amiodarone Impurity HCl CAS CATO-C4X-142546

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-142546
Molecular FormulaC20H23I2NO2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Amiodarone Impurity HCl CAS CATO-C4X-142546 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Amiodarone Impurity HCl.

Amiodarone Impurity HCl (CAS CATO-C4X-142546) is a certified pharmaceutical impurity reference standard with the molecular formula C20H23I2NO2HCl and a molecular weight of 599.67 g/mol.

Based on its molecular formula C20H23I2NO2HCl, Amiodarone Impurity HCl contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine/iodine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 599.67 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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), Amiodarone Impurity HCl 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 FormulaC20H23I2NO2 HCl
Molecular Weight599.67 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl/I-containing
Nitrogen Atoms1

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