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Impurity reference standards

Clarithromycin impurity standards

20 characterised compounds linked to Clarithromycin are catalogued here, from named pharmacopoeial impurities to synthesis intermediates and breakdown products. Highlights of the range are 17 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue and 1 degradation product.

20reference materials
17pharmacopoeial
1metabolites
1degradants
Clarithromycin structure
Parent API

Clarithromycin

CAS
81103-11-9
Formula
C38H69NO13
MW
748 g/mol
Code
ZX-003919

Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions.

By impurity type

Pharmacopoeial17EP, USP, BP or JP named impurities
Metabolites1Hydroxy, desmethyl and conjugated forms
Degradants1N-oxides, dimers, lactones and breakdown products

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

All Clarithromycin reference materials

1–20 of 20 standards
Questions

Clarithromycin impurities, answered

How many Clarithromycin impurity standards does Zemixal list?
The catalogue currently lists 20 compounds for Clarithromycin, including 17 pharmacopoeial impurities, 1 metabolite or hydroxylated analogue 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 Clarithromycin 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 Clarithromycin 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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