Impurity reference standards
Gefitinib impurity standards
This page brings together 19 Gefitinib related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 2 pharmacopoeial impurities, 1 isotope-labelled standard, 2 metabolites or hydroxylated analogues and 1 degradation product.
19reference materials
2pharmacopoeial
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. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.
By impurity type
Pharmacopoeial2EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, 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 Gefitinib reference materials
1–19 of 19 standards
3-(3-Chloro-4-fluorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4(3H)-one
- CAS
- 1608115-59-8
- Formula
- C22H23ClFN3O4
- MW
- 447.9 g/mol
ZX-029706
3,4-Dihydro-7-methoxy-4-oxoquinazolin-6-yl acetate
- CAS
- 179688-53-0
- Formula
- C11H10N2O4
- MW
- 234.21 g/mol
ZX-029705
4-Methoxy-5-(3-morpholinopropoxy)-2-nitrobenzonitrile
- CAS
- 675126-26-8
- Formula
- C15H19N3O5
- MW
- 321.33 g/mol
ZX-029707
Questions
Gefitinib impurities, answered
What Gefitinib reference materials are available?
The catalogue currently lists 19 compounds for Gefitinib, including 2 pharmacopoeial impurities, 1 isotope-labelled standard, 2 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 Gefitinib 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 Gefitinib 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 Gefitinib standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.