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Impurity reference standards

Antipyrine impurity standards

For Antipyrine, the Zemixal catalogue holds 6 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 2 nitrosamines, 1 isotope-labelled standard and 1 metabolite or hydroxylated analogue.

6reference materials
2nitrosamines
1isotope labelled
1metabolites

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. For nitrosamine risk evaluation, the N-nitroso standards allow confirmatory LC-MS testing against the acceptable intake limits.

By impurity type

Nitrosamines2N-nitroso impurities for ICH M7 work
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 Antipyrine reference materials

Questions

Antipyrine impurities, answered

What Antipyrine reference materials are available?
The catalogue currently lists 6 compounds for Antipyrine, including 2 nitrosamines, 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 Antipyrine 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 Antipyrine 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.
Do you supply Antipyrine nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Antipyrine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Antipyrine 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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