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Impurity reference standards

Ponatinib impurity standards

Zemixal lists 11 reference materials related to Ponatinib, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 metabolite or hydroxylated analogue and 1 degradation product.

11reference materials
1metabolites
1degradants

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
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Ponatinib reference materials

1–11 of 11 standards
Questions

Ponatinib impurities, answered

How many Ponatinib impurity standards does Zemixal list?
The catalogue currently lists 11 compounds for Ponatinib, including 1 metabolite or hydroxylated analogue 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 Ponatinib 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 Ponatinib 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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