Impurity reference standards
Azelastine impurity standards
18 characterised compounds linked to Azelastine are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 5 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 3 degradation products.
18reference materials
5pharmacopoeial
1metabolites
3degradants
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
Pharmacopoeial5EP, USP, BP or JP named impurities
Metabolites1Hydroxy, 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 Azelastine reference materials
1–18 of 18 standards
4-Benzyl-2-(1-methylazepan-4-yl)phthalazin-1(2H)-one
- CAS
- 47491-39-4
- Formula
- C22H25N3O
- MW
- 347.5 g/mol
ZX-028177
Questions
Azelastine impurities, answered
How many Azelastine impurity standards does Zemixal list?
The catalogue currently lists 18 compounds for Azelastine, including 5 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue 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 Azelastine 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 Azelastine 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.