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Impurity reference standards

Cephalexin impurity standards

For Cephalexin, the Zemixal catalogue holds 12 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 2 pharmacopoeial impurities.

12reference materials
2pharmacopoeial

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. 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

Pharmacopoeial2EP, USP, BP or JP named impurities

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

All Cephalexin reference materials

1–12 of 12 standards
Questions

Cephalexin impurities, answered

What Cephalexin reference materials are available?
The catalogue currently lists 12 compounds for Cephalexin, including 2 pharmacopoeial impurities. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Cephalexin 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 Cephalexin 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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