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Nitrosamines are chemical compounds, usually formed by the reaction of nitrites and secondary amines. They can be formed both naturally and during industrial processes. Nitrosamines, which can occur unintentionally in foods, tobacco products and especially in the production processes of some pharmaceuticals, have carcinogenic potential in case of long-term exposure.
Some raw materials, solvents or process aids used during drug production can trigger the formation of nitrosamines. In particular, amine-based substances used in the production of active pharmaceutical ingredients (APIs) and conditions such as high temperatures can predispose to the formation of these compounds.
In recent years, high levels of nitrosamines have been detected in the controls of drugs such as valsartan, ranitidine and metformin, leading to major recalls worldwide. This has highlighted the importance of nitrosamines for drug safety and prompted regulators to take action.
Some types of nitrosamines (e.g. NDMA and NDEA) have been classified as probable human carcinogens based on animal studies and epidemiological data. Long-term and high doses may cause tumor formation in various organs, especially the liver.
Organizations such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the Turkish Medicines and Medical Devices Agency (TİTCK) require pharmaceutical companies to carry out regular nitrosamine controls. Companies are obliged to perform nitrosamine risk assessments and necessary analyses for both new products and existing products on the market.
In order to ensure the safety of medicines, nitrosamine analyses must be performed during the production process and on the final product. Thanks to these analyzes, it can be documented that the products contain nitrosamines below legal limits.
Which Methods Are Used?
These advanced techniques allow to detect the presence of nitrosamines even at low levels. As regulations often set limits at ng levels, the analysis needs to be extremely sensitive.
Nanolab Laboratories Group continues to provide services within the scope of Pharmaceutical Analysis. You can also consult us on Pharmaceutical Water for Use Analysis.
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