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Impurity reference standards

Atenolol impurity standards

Zemixal lists 22 reference materials related to Atenolol, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 10 pharmacopoeial impurities, 1 nitrosamine, 3 isotope-labelled standards and 5 metabolites or hydroxylated analogues.

22reference materials
10pharmacopoeial
1nitrosamines
3isotope labelled

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. 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

Pharmacopoeial10EP, USP, BP or JP named impurities
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled3Deuterated, 13C or 15N internal standards
Metabolites5Hydroxy, desmethyl and conjugated forms

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

All Atenolol reference materials

1–22 of 22 standards
Questions

Atenolol impurities, answered

How many Atenolol impurity standards does Zemixal list?
The catalogue currently lists 22 compounds for Atenolol, including 10 pharmacopoeial impurities, 1 nitrosamine, 3 isotope-labelled standards and 5 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 Atenolol 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 Atenolol 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 Atenolol nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Atenolol. 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 Atenolol standards available?
Yes. 3 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.
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