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Impurity reference standards

Betahistine impurity standards

Zemixal lists 18 reference materials related to Betahistine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 4 pharmacopoeial impurities, 1 nitrosamine, 2 isotope-labelled standards and 1 metabolite or hydroxylated analogue.

18reference materials
4pharmacopoeial
1nitrosamines
2isotope labelled

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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.

By impurity type

Pharmacopoeial4EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
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 Betahistine reference materials

1–18 of 18 standards
Questions

Betahistine impurities, answered

How many Betahistine impurity standards does Zemixal list?
The catalogue currently lists 18 compounds for Betahistine, including 4 pharmacopoeial impurities, 1 nitrosamine, 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 Betahistine 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 Betahistine 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 Betahistine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Betahistine. 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 Betahistine 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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