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Impurity reference standards

Nefopam impurity standards

Zemixal lists 10 reference materials related to Nefopam, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 5 metabolites or hydroxylated analogues and 1 degradation product.

10reference materials
5metabolites
1degradants

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.

By impurity type

Metabolites5Hydroxy, 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 Nefopam reference materials

1–10 of 10 standards
Questions

Nefopam impurities, answered

How many Nefopam impurity standards does Zemixal list?
The catalogue currently lists 10 compounds for Nefopam, including 5 metabolites or hydroxylated analogues 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 Nefopam 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 Nefopam 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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