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Impurity reference standards

Metamizole impurity standards

For Metamizole, the Zemixal catalogue holds 16 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 5 pharmacopoeial impurities, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue.

16reference materials
5pharmacopoeial
1isotope labelled
1metabolites

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

Pharmacopoeial5EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Metamizole reference materials

1–16 of 16 standards
Questions

Metamizole impurities, answered

What Metamizole reference materials are available?
The catalogue currently lists 16 compounds for Metamizole, including 5 pharmacopoeial impurities, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Metamizole 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 Metamizole 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 Metamizole 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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