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Impurity reference standards

Dofetilide impurity standards

For Dofetilide, the Zemixal catalogue holds 20 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 isotope-labelled standard, 3 metabolites or hydroxylated analogues and 1 degradation product.

20reference materials
1isotope labelled
3metabolites
1degradants

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

Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites3Hydroxy, 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 Dofetilide reference materials

1–20 of 20 standards
Questions

Dofetilide impurities, answered

What Dofetilide reference materials are available?
The catalogue currently lists 20 compounds for Dofetilide, including 1 isotope-labelled standard, 3 metabolites or hydroxylated analogues 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 Dofetilide 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 Dofetilide 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 Dofetilide 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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