N-(4-((3-Chloro-4-(pyridin-2-ylmethoxy)phenyl)amino)-3-cyano-7-ethoxyquinolin-6-yl)formamide
- CAS
- 1144516-20-0
- Formula
- C25H20ClN5O3
- MW
- 473.9 g/mol
ZX-027811
Impurity reference standards
Neratinib impurity standards
Zemixal lists 12 reference materials related to Neratinib, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 nitrosamine, 1 isotope-labelled standard, 2 metabolites or hydroxylated analogues and 2 degradation products.
12reference materials
1nitrosamines
1isotope labelled
2metabolites
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. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
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 Neratinib reference materials
1–12 of 12 standards
Questions
Neratinib impurities, answered
How many Neratinib impurity standards does Zemixal list?
The catalogue currently lists 12 compounds for Neratinib, including 1 nitrosamine, 1 isotope-labelled standard, 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 Neratinib 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 Neratinib 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 Neratinib nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Neratinib. 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 Neratinib standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.