Impurity reference standards
Cytisine impurity standards
Zemixal lists 3 reference materials related to Cytisine, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 1 nitrosamine.
3reference materials
1nitrosamines
Each lot ships with a certificate of analysis, and characterisation data such as 1H-NMR, mass spectrum and HPLC purity can be shared before you order. Typical uses are method development and validation, relative response factor work, forced degradation studies and the impurity sections of ANDA, DMF or CEP filings. 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 Cytisine reference materials
1–3 of 3 standards
Questions
Cytisine impurities, answered
How many Cytisine impurity standards does Zemixal list?
The catalogue currently lists 3 compounds for Cytisine, 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 Cytisine 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 Cytisine 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 Cytisine nitrosamine impurities?
Yes. 1 N-nitroso compound is listed for Cytisine. They are used for confirmatory testing and method validation in line with ICH M7 and the nitrosamine guidance from the major regulators.