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Impurity reference standards

Crisaborole impurity standards

This page brings together 14 Crisaborole related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 7 metabolites or hydroxylated analogues.

14reference materials
7metabolites

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

Metabolites7Hydroxy, desmethyl and conjugated forms

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

All Crisaborole reference materials

1–14 of 14 standards
Questions

Crisaborole impurities, answered

What Crisaborole reference materials are available?
The catalogue currently lists 14 compounds for Crisaborole, including 7 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Crisaborole 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 Crisaborole 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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