Impurity reference standards
Dirithromycin impurity standards
This page brings together 2 Dirithromycin related compounds that analytical teams use to identify, quantify and control impurities in the active ingredient and the finished dosage form. The range includes 1 pharmacopoeial impurity.
2reference materials
1pharmacopoeial
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. 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
Pharmacopoeial1EP, USP, BP or JP named impurities
Counts are based on product names. One compound can fall into more than one type.
All Dirithromycin reference materials
1–2 of 2 standards
Questions
Dirithromycin impurities, answered
What Dirithromycin reference materials are available?
The catalogue currently lists 2 compounds for Dirithromycin, including 1 pharmacopoeial impurity. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Dirithromycin 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 Dirithromycin 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.