Impurity reference standards
Regorafenib impurity standards
Zemixal lists 19 reference materials related to Regorafenib, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 pharmacopoeial impurity, 1 isotope-labelled standard, 3 metabolites or hydroxylated analogues and 3 degradation products.
19reference materials
1pharmacopoeial
1isotope labelled
3metabolites
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. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.
By impurity type
Pharmacopoeial1EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, desmethyl and conjugated forms
Degradants3N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Regorafenib reference materials
1–19 of 19 standards
4-(4-(3-(4-Chloro-3-(trifluoromethyl)phenyl)ureido)-3-fluorophenoxy)picolinic Acid
- CAS
- 1187945-05-6
- Formula
- C20H12ClF4N3O4
- MW
- 469.8 g/mol
ZX-032138
Questions
Regorafenib impurities, answered
How many Regorafenib impurity standards does Zemixal list?
The catalogue currently lists 19 compounds for Regorafenib, including 1 pharmacopoeial impurity, 1 isotope-labelled standard, 3 metabolites or hydroxylated analogues and 3 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Regorafenib 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 Regorafenib 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.
Are isotope-labelled Regorafenib standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.