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Impurity reference standards

Dacomitinib impurity standards

For Dacomitinib, the Zemixal catalogue holds 2 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 metabolite or hydroxylated analogue.

2reference materials
1metabolites
Dacomitinib structure
Parent API

Dacomitinib

CAS
1110813-31-4
Formula
C24H25ClFN5O2
MW
469.9 g/mol
Code
ZX-006482

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

Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Dacomitinib reference materials

Questions

Dacomitinib impurities, answered

What Dacomitinib reference materials are available?
The catalogue currently lists 2 compounds for Dacomitinib, including 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Dacomitinib 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 Dacomitinib 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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