Impurity reference standards
Citiolone impurity standards
Zemixal lists 2 reference materials related to Citiolone, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 degradation product.
2reference materials
1degradants
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. 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
Degradants1N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Citiolone reference materials
1–2 of 2 standards
Questions
Citiolone impurities, answered
How many Citiolone impurity standards does Zemixal list?
The catalogue currently lists 2 compounds for Citiolone, including 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 Citiolone 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 Citiolone 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.