Impurity reference standards
Amphotericin B impurity standards
Zemixal lists 5 reference materials related to Amphotericin B, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 3 pharmacopoeial impurities.
5reference materials
3pharmacopoeial
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
Pharmacopoeial3EP, USP, BP or JP named impurities
Counts are based on product names. One compound can fall into more than one type.
All Amphotericin B reference materials
1–5 of 5 standards
Questions
Amphotericin B impurities, answered
How many Amphotericin B impurity standards does Zemixal list?
The catalogue currently lists 5 compounds for Amphotericin B, including 3 pharmacopoeial impurities. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Amphotericin B 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 Amphotericin B 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.