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Impurity reference standards

Sofosbuvir impurity standards

35 characterised compounds linked to Sofosbuvir are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 1 isotope-labelled standard, 5 metabolites or hydroxylated analogues and 1 degradation product.

35reference materials
1isotope labelled
5metabolites
1degradants

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

Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites5Hydroxy, 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 Sofosbuvir reference materials

1–35 of 35 standards
Questions

Sofosbuvir impurities, answered

How many Sofosbuvir impurity standards does Zemixal list?
The catalogue currently lists 35 compounds for Sofosbuvir, including 1 isotope-labelled standard, 5 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 Sofosbuvir 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 Sofosbuvir 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 Sofosbuvir 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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