Impurity reference standards
Nitroso Impurity impurity standards
Zemixal lists 2 reference materials related to Nitroso Impurity, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 2 nitrosamines.
2reference materials
2nitrosamines
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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Nitrosamines2N-nitroso impurities for ICH M7 work
Counts are based on product names. One compound can fall into more than one type.
All Nitroso Impurity reference materials
1–2 of 2 standards
Questions
Nitroso Impurity impurities, answered
How many Nitroso Impurity impurity standards does Zemixal list?
The catalogue currently lists 2 compounds for Nitroso Impurity, including 2 nitrosamines. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Nitroso Impurity 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 Nitroso Impurity 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 Nitroso Impurity nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Nitroso Impurity. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.