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Impurity reference standards

Nebivolol impurity standards

40 characterised compounds linked to Nebivolol are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 3 pharmacopoeial impurities, 1 nitrosamine and 4 metabolites or hydroxylated analogues.

40reference materials
3pharmacopoeial
1nitrosamines
4metabolites

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

By impurity type

Pharmacopoeial3EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Metabolites4Hydroxy, desmethyl and conjugated forms

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

All Nebivolol reference materials

1–40 of 40 standards
Questions

Nebivolol impurities, answered

How many Nebivolol impurity standards does Zemixal list?
The catalogue currently lists 40 compounds for Nebivolol, including 3 pharmacopoeial impurities, 1 nitrosamine and 4 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Nebivolol 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 Nebivolol 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 Nebivolol nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Nebivolol. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.

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