(3E)-1-Acetyl-3-(ethoxyphenylmethylene)-2,3-dihydro-2-oxo-1H-indole-6-carboxylic Acid Methyl Ester
- CAS
- 1168152-06-4
- Formula
- C21H19NO5
- MW
- 365.4 g/mol
ZX-030867
Impurity reference standards
Nintedanib impurity standards
Zemixal lists 52 reference materials related to Nintedanib, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 5 nitrosamines, 3 metabolites or hydroxylated analogues and 1 degradation product.
52reference materials
5nitrosamines
3metabolites
1degradants
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
Nitrosamines5N-nitroso impurities for ICH M7 work
Metabolites3Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Nintedanib reference materials
1–52 of 52 standards
(E)-Methyl 1-acetyl-3-(methoxy(phenyl)methylene)-2-oxoindoline-6-carboxylate
- CAS
- 1168152-07-5
- Formula
- C20H17NO5
- MW
- 351.4 g/mol
ZX-025844
(Z)-Methyl 3-(1-methoxypropylidene)-2-oxo-1-propionylindoline-6-carboxylate
- Formula
- C17H19NO5
- MW
- 317.34 g/mol
ZX-011868
2,2'-(Piperazine-1,4-diyl)bis(N-(4-aminophenyl)-N-methylacetamide)
- CAS
- 2410284-89-6
- Formula
- C22H30N6O2
- MW
- 410.5 g/mol
ZX-025842
Dimethyl 2-(4-(methoxycarbonyl)-2-nitrophenyl)malonate
- CAS
- 1160293-27-5
- Formula
- C13H13NO8
- MW
- 311.24 g/mol
ZX-022283
N-(2-Aminophenyl)-N-methyl-2-(4-methylpiperazin-1-yl)acetamide
- CAS
- 2117628-65-4
- Formula
- C14H22N4O
- MW
- 262.35 g/mol
ZX-030866
N-Methyl-2-(4-methylpiperazin-1-yl)-N-(4-nitrophenyl)acetamide
- CAS
- 1139453-98-7
- Formula
- C14H20N4O3
- MW
- 292.33 g/mol
ZX-025846
Nintedanib N-Methyl Aniline Intermediate (n-1)
- CAS
- 1987887-92-2
- Formula
- C24H21N3O3
- MW
- 399.4 g/mol
ZX-012719
Nintedanib N-Methyl Aniline Intermediate (n-1)(Hydrochloride)
- Formula
- C24H21N3O3.ClH
- MW
- 435.9 g/mol
ZX-012720
Nintedanib N-Methyl Aniline Intermediate (Stage-I)
- CAS
- 474020-88-7
- Formula
- C12H16N2O4
- MW
- 252.27 g/mol
ZX-012722
Questions
Nintedanib impurities, answered
How many Nintedanib impurity standards does Zemixal list?
The catalogue currently lists 52 compounds for Nintedanib, including 5 nitrosamines, 3 metabolites or hydroxylated analogues and 1 degradation product. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Nintedanib 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 Nintedanib 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 Nintedanib nitrosamine impurities?
Yes. 5 N-nitroso compounds are listed for Nintedanib. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.