Impurity reference standards
Aniline impurity standards
Zemixal lists 5 reference materials related to Aniline, covering the drug substance itself, its process impurities and the products it forms on storage. Among them are 2 nitrosamines and 1 isotope-labelled standard.
5reference materials
2nitrosamines
1isotope labelled
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. The nitrosamine entries support ICH M7 risk assessments and confirmatory testing at trace levels.
By impurity type
Nitrosamines2N-nitroso impurities for ICH M7 work
Isotope labelled1Deuterated, 13C or 15N internal standards
Counts are based on product names. One compound can fall into more than one type.
All Aniline reference materials
1–5 of 5 standards
Questions
Aniline impurities, answered
How many Aniline impurity standards does Zemixal list?
The catalogue currently lists 5 compounds for Aniline, including 2 nitrosamines and 1 isotope-labelled standard. Each product page shows the CAS number where one is assigned, the structure, formula and molecular weight.
What documents come with a Aniline 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 Aniline 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 Aniline nitrosamine impurities?
Yes. 2 N-nitroso compounds are listed for Aniline. 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 Aniline standards available?
Yes. 1 stable-isotope labelled compound is listed, suitable as internal standards for LC-MS bioanalysis and trace impurity quantitation.