As a pharmaceutical manufacturer, you need to know whether your products contain nitrosamine impurities and, if so, whether they are below the thresholds established by various regulatory agencies.
Nitrosamine impurities can be introduced at any stage in the supply chain, during manufacturing, or as leachables from packaging and storage.
Nitrosamines are highly toxic compounds, and some are considered even more carcinogenic than currently established thresholds suggest and are subject to strict regulations in both the EU and the US.
At SAXOCON, we have the expertise and services to help you to fill in the gaps in your supply chain information, and test and assess your manufacturing, packaging, and storage processes for the presence of nitrosamines and how they impact your drug substances and products.
Check out how we can help here.