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Impurity reference standards

Cefaclor impurity standards

For Cefaclor, the Zemixal catalogue holds 9 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 5 pharmacopoeial impurities and 1 degradation product.

9reference materials
5pharmacopoeial
1degradants

Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Pharmacopoeial5EP, USP, BP or JP named impurities
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Cefaclor reference materials

Questions

Cefaclor impurities, answered

What Cefaclor reference materials are available?
The catalogue currently lists 9 compounds for Cefaclor, including 5 pharmacopoeial impurities 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 Cefaclor 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 Cefaclor 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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