Impurity reference standards
Azithromycin impurity standards
For Azithromycin, the Zemixal catalogue holds 22 impurity and reference standards that support release testing, stability programmes and regulatory dossiers. Counted by type, there are 11 pharmacopoeial impurities, 1 isotope-labelled standard and 2 metabolites or hydroxylated analogues.
22reference materials
11pharmacopoeial
1isotope labelled
2metabolites
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
Pharmacopoeial11EP, USP, BP or JP named impurities
Isotope labelled1Deuterated, 13C or 15N internal standards
Metabolites2Hydroxy, desmethyl and conjugated forms
Counts are based on product names. One compound can fall into more than one type.
All Azithromycin reference materials
1–22 of 22 standards
Questions
Azithromycin impurities, answered
What Azithromycin reference materials are available?
The catalogue currently lists 22 compounds for Azithromycin, including 11 pharmacopoeial impurities, 1 isotope-labelled standard and 2 metabolites or hydroxylated analogues. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Azithromycin 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 Azithromycin 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.
Are isotope-labelled Azithromycin standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.