Amiodarone Impurity I CAS CATO-C4X-142515

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-142515
Molecular FormulaC21H20I2O3
Molecular Weight574.19 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Amiodarone Impurity I CAS CATO-C4X-142515 chemical structure

Description

Based on its molecular formula C21H20I2O3, Amiodarone Impurity I contains a steroid core, a hydroxyl group, an ether linkage, iodine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 574.19 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

CATO supplies Amiodarone Impurity I (CAS CATO-C4X-142515), a pharmacopoeial impurity reference standard (molecular formula C21H20I2O3, MW 574.19 g/mol) used for the identification and quantification of trace impurities in APIs.

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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC21H20I2O3
Molecular Weight574.19 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
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)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentI-containing

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