Impurity reference standards
Lubiprostone impurity standards
Zemixal lists 4 reference materials related to Lubiprostone, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 degradation product.
4reference materials
1degradants
Every standard comes with a certificate of analysis. Structure confirmation data, typically NMR, MS and chromatographic purity, is available on request. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings.
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 Lubiprostone reference materials
1–4 of 4 standards
Questions
Lubiprostone impurities, answered
How many Lubiprostone impurity standards does Zemixal list?
The catalogue currently lists 4 compounds for Lubiprostone, 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 Lubiprostone 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 Lubiprostone 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.