What are nitrosamines?

Nitrosamines are a class of organic compounds characterized by the presence of a nitroso group (N=O) bonded to a nitrogen atom. They are formed primarily through the reaction of nitrous acid with secondary amines, often occurring in various foods, tobacco products, and even pharmaceuticals.
Main health Impact of Nitrosamines
Carcinogenic Properties:
Many nitrosamines have been identified as probable human carcinogens based on animal studies. Research indicates that exposure to nitrosamines can lead to various types of cancer, particularly gastric and esophageal cancers. A systematic review has shown a positive association between dietary intake of nitrites and nitrosamines and the risk of these cancers
Sources of Exposure: Common sources of nitrosamines include:
• Tobacco Products: Tobacco-specific nitrosamines are prevalent in cigarette smoke and smokeless tobacco, contributing significantly to cancer risk in smokers
• Processed Foods: Certain foods, especially those preserved with nitrates and nitrites (like cured meats), can form nitrosamines during cooking or digestion, particularly in acidic environments like the stomach
• Pharmaceuticals: Recent investigations have revealed the presence of nitrosamine impurities in some medications, leading to recalls due to potential cancer risks associated with long-term exposure
Mechanism of Action:
Nitrosamines are not directly carcinogenic; they require metabolic activation to convert into reactive alkylating agents that can damage DNA, leading to mutations. This process highlights the importance of understanding both exposure levels and biological mechanisms in assessing health risks.
To reduce the exposure to nitrosamine coming from the pharmaceutical products the producers of human medicinal products should ensure that the presence of nitrosamines is controlled and kept as low as possible, irrespective of the marketing status or the type of product.
In order to do that the content of nitrosamines in different pharmaceutical products have to be detected and quantified. Confirmatory tests shall be conducted by the producers and manufacturers or sub-contracted to a laboratory capable to perform this kind of analyses.

We at 3S Pharma are experienced in nitrosamine detection and quantitation.
We do have analytical methods sufficiently sensitive to determine trace levels of nitrosamine impurities.

We are at your disposal with this kind of analysis, do not hesitate to contact us (3s-office@3spharma.net) if you want/need to determine the nitrosamine level in your API or final product !!!