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Impurity reference standards

Asenapine impurity standards

Zemixal lists 25 reference materials related to Asenapine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 2 metabolites or hydroxylated analogues and 4 degradation products.

25reference materials
2metabolites
4degradants
Asenapine structure
Parent API

Asenapine

CAS
65576-45-6
Formula
C17H16ClNO
MW
285.8 g/mol
Code
ZX-006402

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.

By impurity type

Metabolites2Hydroxy, desmethyl and conjugated forms
Degradants4N-oxides, dimers, lactones and breakdown products

Counts are based on product names. One compound can fall into more than one type.

All Asenapine reference materials

1–25 of 25 standards
Questions

Asenapine impurities, answered

How many Asenapine impurity standards does Zemixal list?
The catalogue currently lists 25 compounds for Asenapine, including 2 metabolites or hydroxylated analogues and 4 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Asenapine 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 Asenapine 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.
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