Impurity reference standards
Cysteamine impurity standards
Zemixal lists 13 reference materials related to Cysteamine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 nitrosamine.
13reference materials
1nitrosamines
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. They are bought for system suitability, peak identification, quantitation against limits and the impurity justification sections of regulatory submissions. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Nitrosamines1N-nitroso impurities for ICH M7 work
Counts are based on product names. One compound can fall into more than one type.
All Cysteamine reference materials
1–13 of 13 standards
Questions
Cysteamine impurities, answered
How many Cysteamine impurity standards does Zemixal list?
The catalogue currently lists 13 compounds for Cysteamine, including 1 nitrosamine. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Cysteamine 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 Cysteamine 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.
Do you supply Cysteamine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Cysteamine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.