Ethambutol EP Impurity B (2R,2’S-Ethambutol) DiHCl CAS 32454-69-6

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ethambutol EP Impurity B (2R,2’S-Ethambutol) DiHCl.

As a process- or degradation-related impurity, Ethambutol EP Impurity B (2R,2’S-Ethambutol) DiHCl (CAS 32454-69-6, C10H24N2O2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C10H24N2O2HCl, Ethambutol EP Impurity B (2R,2’S-Ethambutol) DiHCl contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 240.77 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.

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

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