Amiodarone Hydrochloride EP Impurity C CAS 1397201-93-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1397201-93-2
Molecular FormulaC25H30INO3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Amiodarone Hydrochloride EP Impurity C CAS 1397201-93-2 chemical structure

Description

Amiodarone Hydrochloride EP Impurity C (C25H30INO3HCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine/iodine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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).

Amiodarone Hydrochloride EP Impurity C (CAS 1397201-93-2) is a certified pharmaceutical impurity reference standard with the molecular formula C25H30INO3HCl and a molecular weight of 555.88 g/mol.

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 Amiodarone Hydrochloride EP Impurity C 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 FormulaC25H30INO3 HCl
Molecular Weight555.88 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity>95%
StorageStore at room temperature, protect from light, keep sealed and dry
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1991
Halogen ContentCl/I-containing
Nitrogen Atoms1

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