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Impurity reference standards

Topiramate impurity standards

Zemixal lists 9 reference materials related to Topiramate, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 3 pharmacopoeial impurities, 2 isotope-labelled standards and 1 metabolite or hydroxylated analogue.

9reference materials
3pharmacopoeial
2isotope labelled
1metabolites

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

Pharmacopoeial3EP, USP, BP or JP named impurities
Isotope labelled2Deuterated, 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 Topiramate reference materials

Questions

Topiramate impurities, answered

How many Topiramate impurity standards does Zemixal list?
The catalogue currently lists 9 compounds for Topiramate, including 3 pharmacopoeial impurities, 2 isotope-labelled standards 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 Topiramate 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 Topiramate 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 Topiramate standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.

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