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Impurity reference standards

Elagolix impurity standards

For Elagolix, the Zemixal catalogue holds 19 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 1 metabolite or hydroxylated analogue and 1 degradation product.

19reference materials
1metabolites
1degradants

Batches are supplied with a certificate of analysis, and the supporting spectra can be sent ahead of a purchase order so your QA team can review them. Laboratories use them to validate related-substance methods, set specification limits under ICH Q3A and Q3B, and identify unknown peaks in stability samples.

By impurity type

Metabolites1Hydroxy, 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 Elagolix reference materials

1–19 of 19 standards
Questions

Elagolix impurities, answered

What Elagolix reference materials are available?
The catalogue currently lists 19 compounds for Elagolix, including 1 metabolite or hydroxylated analogue 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 Elagolix 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 Elagolix 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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