Impurity reference standards
Osimertinib impurity standards
For Osimertinib, the Zemixal catalogue holds 32 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 2 metabolites or hydroxylated analogues and 2 degradation products.
32reference materials
2metabolites
2degradants
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.
By impurity type
Metabolites2Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Osimertinib reference materials
1–32 of 32 standards
2-Methoxy-N4,N4-dimethyl-N1-(4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)-5-nitrobenzene-1,4-diamine
- CAS
- 1820891-36-8
- Formula
- C22H22N6O3
- MW
- 418.4 g/mol
ZX-030991
3-(2-Chloropyrimidin-4-yl)-1-methyl-1H-indole
- CAS
- 1032452-86-0
- Formula
- C13H10ClN3
- MW
- 243.69 g/mol
ZX-033980
3,3`-(Pyrimidine-2,4-diyl)bis(1-methyl-1H-indole)
- CAS
- 2364486-24-6
- Formula
- C22H18N4
- MW
- 338.4 g/mol
ZX-039516
5-Methoxy-N1,N1-dimethyl-N4-(4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)benzene-1,2,4-triamine hydrochloride
- CAS
- 2044702-55-6
- Formula
- C22H25ClN6O
- MW
- 424.9 g/mol
ZX-030996
N-(2-((2-Acrylamido-5-methoxy-4-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)(methyl)amino)ethyl)-3-((2-((2-(dimethylamino)ethyl)(methyl)amino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)amino)-N,N-dimethyl-3-oxopropan-1-aminium
- CAS
- 2564638-97-5
- Formula
- C56H67N14O4+
- MW
- 1000.2 g/mol
ZX-025981
N-(4-fluoro-2-methoxy-5-nitrophenyl)-4-(1-methyl-1H-indol-3-yl)pyrimidin-2-amine
- CAS
- 1421372-94-2
- Formula
- C20H16FN5O3
- MW
- 393.4 g/mol
ZX-012664
N-(5-((4-(1H-Indol-3-yl)pyrimidin-2-yl)amino)-2-((2-(dimethylamino)ethyl)(methyl)amino)-4-methoxyphenyl)acrylamide
- CAS
- 1421373-98-9
- Formula
- C27H31N7O2
- MW
- 485.6 g/mol
ZX-025977
N1,N5-Bis(2-((2-(Dimethylamino)ethyl)(methyl)amino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)-2-methylenepentanediamide
- CAS
- 2945220-41-5
- Formula
- C56H66N14O4
- MW
- 999.2 g/mol
ZX-030995
O-Des Methyl Osimertinib Intermediate (Stage-1)
- CAS
- 1801616-73-8
- Formula
- C20H18FN5O
- MW
- 363.4 g/mol
ZX-012729
Questions
Osimertinib impurities, answered
What Osimertinib reference materials are available?
The catalogue currently lists 32 compounds for Osimertinib, including 2 metabolites or hydroxylated analogues and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Osimertinib 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 Osimertinib 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.