Dronedarone Impurity 42 CAS 113385-32-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.113385-32-3
Molecular FormulaC11H24BrN
Molecular Weight250.22 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dronedarone Impurity 42 CAS 113385-32-3 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 Dronedarone Impurity 42.

Dronedarone Impurity 42 (CAS 113385-32-3) is a certified pharmaceutical impurity reference standard with the molecular formula C11H24BrN and a molecular weight of 250.22 g/mol.

Dronedarone Impurity 42 (C11H24BrN) contains bromine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

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 FormulaC11H24BrN
Molecular Weight250.22 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)0.0
CAS Registry Year (est.)1989
Halogen ContentBr-containing
Nitrogen Atoms1

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