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Impurity reference standards

Deferasirox impurity standards

Zemixal lists 22 reference materials related to Deferasirox, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 5 pharmacopoeial impurities, 1 isotope-labelled standard and 3 metabolites or hydroxylated analogues.

22reference materials
5pharmacopoeial
1isotope labelled
3metabolites

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.

By impurity type

Pharmacopoeial5EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, desmethyl and conjugated forms

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

All Deferasirox reference materials

1–22 of 22 standards
Questions

Deferasirox impurities, answered

How many Deferasirox impurity standards does Zemixal list?
The catalogue currently lists 22 compounds for Deferasirox, including 5 pharmacopoeial impurities, 1 isotope-labelled standard and 3 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 Deferasirox 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 Deferasirox 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.
Are isotope-labelled Deferasirox standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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