Genotoxic Impurity
An impurity that can damage DNA and potentially cause mutations or cancer, even at very low levels. Such impurities often contain structural alerts such as alkyl halides, epoxides, aromatic amines or N-nitroso groups. Because their acceptable limits are in the ppm or ppb range, they require sensitive analytical methods, typically LC-MS or GC-MS, and well-characterised reference standards.
Related terms
ICH M7
The ICH guideline on assessment and control of DNA-reactive, potentially mutagenic impurities in pharmaceutic…
LOD and LOQ
The limit of detection (LOD) is the lowest amount of analyte that a method can reliably distinguish from back…
Nitrosamine
An organic compound containing the N-N=O group, formed when a secondary or tertiary amine reacts with a nitro…
Have a list of compounds to price?
Paste up to 200 CAS numbers into Bulk CAS lookup, or send one enquiry for everything in your quote list. We reply with price, lead time and documents.