Nitrosamines, or more correctly N-Nitrosamines, refer to any molecule containing the nitroso functional group. These molecules are of concern because nitrosamine impurities are probable human carcinogens. Although they are also present in some foods and drinking water supplies, their presence in medicines is nonetheless considered unacceptable. To ensure the safety of the Global drug supply, the manufacturers are required to investigate the potential risk of N-Nitrosamines within approved or marketed products. There are many guidance documents published through individual authorities that seek to address this and define the specific need of any such assessment. In Europe, this is defined in a 3-step process
This sounds straightforward, but the reality is very different, particularly in terms of the evolving issues surrounding complex API-like N-Nitrosamines, often the Nitrosamine of the active itself. Challenges include- understanding the levels formed, establishing an appropriate acceptable intake, and thereafter control, while at the same time ensuring continued access to essential medicines
