Nitrosamine Analysis (In Food and Pharmaceuticals)

The European Medicines Agency (EMA) assesses the risk of nitrosamine formation or presence during the manufacture of medicines and provides guidance to manufacturers to avoid the presence of nitrosamine impurities.

Nitrosamines are chemical compounds classified as possible human carcinogens. Nitrosamine impurities were first identified in blood pressure medications in 2018. The risk of nitrsosamine impurities at the levels found in drugs to cause cancer in humans is extremely low. However, manufacturers must examine all chemical and biological drugs for the possible presence of nitrosamines and test products at risk. In addition, companies need to have appropriate control strategies to prevent or limit the presence of these impurities and improve their production processes when necessary.

The European Medicines Agency (EMA) and national authorities continue to monitor the presence of nitrosamine impurities in medicines and work with marketing authorization holders to address any adverse situation and find quick solutions.

Registration holders must review their manufacturing processes for all products that contain chemically synthesized or biologically active substances to identify and, if necessary, reduce the risk of the presence of nitrosamine impurities.

Nitrosamines are formed by the reaction of secondary or tertiary amines with a nitrosating agent. In foods, the nitrosating agent is usually nitrous anhydride, which consists of nitrite in acidic, aqueous solution. Food components and the physical structure of the food affect the formation of nitrosamines. Ascorbic acid and sulfur dioxide are used to prevent nitrosamine formation in foods. Nitrosamines can be found in many processed foods and beverages in general, such as cured meats, bacon, cheese, whiskey, and beer. The levels in these foods are much higher than those found in purified drinking water in general.

Among the various reasons for product recalls, detection of unacceptable levels of carcinogenic impurities is one of the most serious concerns. The genotoxic and carcinogenic potential of nitrosamines raises a serious safety concern. The US Food and Drug Administration (FDA) published a guideline for the pharmaceutical industry on the control of nitrosamines in drugs last year. Scientific research has found evidence linking nitrosamines with increased cancer rates.

Nitrosamines are produced when a secondary amine is present with a nitrating source. Amines produced as by-products during the production process are converted to nitrosamines in the next synthesis steps if they are not removed properly. Various conditions such as acidity, presence of reducing agents or high temperatures trigger this reaction.

Our organization also provides nitrosamine analysis (in food and medicine) testing services within the framework of national and international standards, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.