Impurity reference standards
Dimethylamine impurity standards
Zemixal lists 2 reference materials related to Dimethylamine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 nitrosamine and 2 isotope-labelled standards.
2reference materials
1nitrosamines
2isotope labelled
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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Nitrosamines1N-nitroso impurities for ICH M7 work
Isotope labelled2Deuterated, 13C or 15N internal standards
Counts are based on product names. One compound can fall into more than one type.
All Dimethylamine reference materials
1–2 of 2 standards
Questions
Dimethylamine impurities, answered
How many Dimethylamine impurity standards does Zemixal list?
The catalogue currently lists 2 compounds for Dimethylamine, including 1 nitrosamine and 2 isotope-labelled standards. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Dimethylamine 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 Dimethylamine 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 Dimethylamine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Dimethylamine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.
Are isotope-labelled Dimethylamine standards available?
Yes. 2 stable-isotope labelled compounds are listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.