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Impurity reference standards

Benzydamine impurity standards

Zemixal lists 17 reference materials related to Benzydamine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 9 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 2 degradation products.

17reference materials
9pharmacopoeial
1metabolites
2degradants

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

Pharmacopoeial9EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants2N-oxides, dimers, lactones and breakdown products

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

All Benzydamine reference materials

1–17 of 17 standards
Questions

Benzydamine impurities, answered

How many Benzydamine impurity standards does Zemixal list?
The catalogue currently lists 17 compounds for Benzydamine, including 9 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 2 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Benzydamine 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 Benzydamine 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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