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Impurity reference standards

Tucatinib impurity standards

For Tucatinib, the Zemixal catalogue holds 10 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 metabolite or hydroxylated analogue.

10reference materials
1metabolites
Tucatinib structure
Parent API

Tucatinib

CAS
937263-43-9
Formula
C26H24N8O2
MW
480.5 g/mol
Code
ZX-006887

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Tucatinib reference materials

1–10 of 10 standards
Questions

Tucatinib impurities, answered

What Tucatinib reference materials are available?
The catalogue currently lists 10 compounds for Tucatinib, 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 Tucatinib 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 Tucatinib 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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