Impurity reference standards
Spironolactone impurity standards
Zemixal lists 9 reference materials related to Spironolactone, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 7 pharmacopoeial impurities and 9 degradation products.
9reference materials
7pharmacopoeial
9degradants
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
Pharmacopoeial7EP, USP, BP or JP named impurities
Degradants9N-oxides, dimers, lactones and breakdown products
Counts are based on product names. One compound can fall into more than one type.
All Spironolactone reference materials
1–9 of 9 standards
Questions
Spironolactone impurities, answered
How many Spironolactone impurity standards does Zemixal list?
The catalogue currently lists 9 compounds for Spironolactone, including 7 pharmacopoeial impurities and 9 degradation products. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Spironolactone 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 Spironolactone 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.