3-(Aminosulfonyl)-5-(dibutylamino)-4-phenoxybenzoic Acid
- CAS
- 1236290-34-8
- Formula
- C21H28N2O5S
- MW
- 420.5 g/mol
ZX-028360
Impurity reference standards
Bumetanide impurity standards
Zemixal lists 11 reference materials related to Bumetanide, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 4 pharmacopoeial impurities, 1 nitrosamine, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue.
11reference materials
4pharmacopoeial
1nitrosamines
1isotope labelled
Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Pharmacopoeial4EP, 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 Bumetanide reference materials
1–11 of 11 standards
Questions
Bumetanide impurities, answered
How many Bumetanide impurity standards does Zemixal list?
The catalogue currently lists 11 compounds for Bumetanide, including 4 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 Bumetanide 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 Bumetanide 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 Bumetanide nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Bumetanide. 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 Bumetanide standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.