Ethambutol EP Impurity C (2R,2’R-Ethambutol) CAS 10054-05-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.10054-05-4
Molecular FormulaC10H24N2O2
Molecular Weight204.31 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ethambutol EP Impurity C (2R,2’R-Ethambutol) CAS 10054-05-4 chemical structure

Description

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.

Ethambutol EP Impurity C (2R,2’R-Ethambutol) (CAS 10054-05-4) is a certified pharmaceutical impurity reference standard with the molecular formula C10H24N2O2 and a molecular weight of 204.31 g/mol.

Ethambutol EP Impurity C (2R,2’R-Ethambutol) (C10H24N2O2) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, 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 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.

Physical & Chemical Properties

Molecular FormulaC10H24N2O2
Molecular Weight204.31 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)0.0
CAS Registry Year (est.)1959
Nitrogen Atoms2

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