Dronedarone Impurity 60 CAS 1250316-60-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1250316-60-9
Molecular FormulaC12H26ClN
Molecular Weight219.79 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Dronedarone Impurity 60 CAS 1250316-60-9 chemical structure

Description

The occurrence of Dronedarone Impurity 60 is closely related to chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Dronedarone Impurity 60 (CAS 1250316-60-9), a pharmacopoeial impurity reference standard (molecular formula C12H26ClN, MW 219.79 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to chlorine substitution, Dronedarone Impurity 60 is typically white to off-white low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 219.79 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC12H26ClN
Molecular Weight219.79 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.)1990
Halogen ContentCl-containing
Nitrogen Atoms1

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