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Impurity reference standards

Erythromycin impurity standards

For Erythromycin, the Zemixal catalogue holds 27 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 8 pharmacopoeial impurities and 1 metabolite or hydroxylated analogue.

27reference materials
8pharmacopoeial
1metabolites
Erythromycin structure
Parent API

Erythromycin

CAS
114-07-8
Formula
C37H67NO13
MW
733.9 g/mol
Code
ZX-003925

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

Pharmacopoeial8EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms

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

All Erythromycin reference materials

1–27 of 27 standards
Questions

Erythromycin impurities, answered

What Erythromycin reference materials are available?
The catalogue currently lists 27 compounds for Erythromycin, including 8 pharmacopoeial impurities and 1 metabolite or hydroxylated analogue. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Erythromycin 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 Erythromycin 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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