Glossary
What is Nitrosamine?
A compound containing the N-nitroso functional group, formed when secondary or tertiary amines react with nitrosating agents such as nitrite. Many nitrosamines are potent mutagenic carcinogens. Regulators including the FDA and EMA require manufacturers to assess medicines for nitrosamine risk, including drug-substance-related nitrosamines, and to control them to acceptable intakes that are often in the tens of nanograms per day.