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Impurity reference standards

Zileuton impurity standards

Zemixal lists 5 reference materials related to Zileuton, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 2 metabolites or hydroxylated analogues.

5reference materials
2metabolites

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Metabolites2Hydroxy, desmethyl and conjugated forms

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

All Zileuton reference materials

Questions

Zileuton impurities, answered

How many Zileuton impurity standards does Zemixal list?
The catalogue currently lists 5 compounds for Zileuton, including 2 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 Zileuton 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 Zileuton 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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