2,4-Dimethyl-1H-pyrrole-3-carboxylic Acid Ethyl Ester
- CAS
- 2199-51-1
- Formula
- C9H13NO2
- MW
- 167.2 g/mol
ZX-034363
Impurity reference standards
Sunitinib impurity standards
This page brings together 28 Sunitinib related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 1 nitrosamine and 1 metabolite or hydroxylated analogue.
28reference materials
1nitrosamines
1metabolites
Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.
By impurity type
Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites1Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Sunitinib reference materials
1–28 of 28 standards
2H-Indol-2-one, 3-[(3,5-dimethyl-1H-pyrrol-2-yl)methylene]-5-fluoro-1,3-dihydro
- CAS
- 856436-17-4
- Formula
- C15H13FN2O
- MW
- 256.27 g/mol
ZX-042531
4-(Ethoxycarbonyl)-3,5-dimethyl-1H-pyrrole-2-carboxylic acid
- CAS
- 5442-91-1
- Formula
- C10H13NO4
- MW
- 211.21 g/mol
ZX-036707
Ethyl 5-formyl-2,4-dimethyl-1H-pyrrole-3-carboxylate
- CAS
- 2199-59-9
- Formula
- C10H13NO3
- MW
- 195.21 g/mol
ZX-045055
Ethyl Ethylene diamine nitroso Impurity (Mixture of Rotamers)
- CAS
- 2680539-26-6
- Formula
- C4H11N3O
- MW
- 117.15 g/mol
ZX-006099
Sunitinib N,N-Didesethyl Hydrochloride Impurity
- CAS
- 1217216-61-9
- Formula
- C18H20ClFN4O2
- MW
- 378.8 g/mol
ZX-006351
Questions
Sunitinib impurities, answered
What Sunitinib reference materials are available?
The catalogue currently lists 28 compounds for Sunitinib, including 1 nitrosamine 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 Sunitinib 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 Sunitinib 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 Sunitinib nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Sunitinib. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.