2,2'-(Ethane-1,2-diylbis(azanediyl))dibutanoic Acid
- CAS
- 498-17-9
- Formula
- C10H20N2O4
- MW
- 232.28 g/mol
ZX-029361
Impurity reference standards
Ethambutol impurity standards
For Ethambutol, the Zemixal catalogue holds 10 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 5 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue.
10reference materials
5pharmacopoeial
1nitrosamines
1isotope labelled
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.
By impurity type
Pharmacopoeial5EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Ethambutol reference materials
1–10 of 10 standards
N-((R)-1-Hydroxybutan-2-yl)-N-(2-(((R)-1-hydroxybutan-2-yl)amino)ethyl)nitrous amide
- CAS
- 78213-39-5
- Formula
- C10H23N3O3
- MW
- 233.31 g/mol
ZX-029360
Questions
Ethambutol impurities, answered
What Ethambutol reference materials are available?
The catalogue currently lists 10 compounds for Ethambutol, including 5 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Ethambutol impurity standard?
A certificate of analysis travels with every lot. On request we share the characterisation set, usually 1H-NMR, mass spectrum, HPLC purity and IR, and for some materials TGA or water content. Ask for the data before ordering if your QA team needs to review it.
Can Zemixal make a Ethambutol impurity that is not listed?
Often yes. Send the structure, name or CAS number with the quantity you need and our sourcing team checks custom synthesis options, usually from 10 mg up to gram scale, with a quoted lead time.
Do you supply Ethambutol nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Ethambutol. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Ethambutol standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.