3 Things to Know About Nitrosamines
Fortunately, drug scandals do not occur too often. However, the recent discovery of nitrosamines in cardiovascular tablets has garnered a lot of attention. The potentially carcinogenic substance had been unknowingly entering the bodies of patients for years, causing great concern among the population. It is therefore important to take a closer look at this chemical substance (or rather, group of substances).
1) What are Nitrosamines?
Nitrosamines, specifically N‑nitrosamines, are a large group of organic compounds that are strongly carcinogenic (as shown in animal studies). They are formed when nitrite reacts with nitrosatable amines. The best-known nitrosamines include nitrosodimethylamine (NDMA), nitrosopyrrolidine (NPYR), and nitrosodiethylamine (NDEA). NDMA has received a lot of attention in recent years as it was found in the aforementioned medication (Ranitidine) and led to its recall. It was formed as a result of changes in the production process of the blood pressure-lowering tablets and remained undetected for a long time, as nitrosamines are not visible during the standard quality control of pharmaceutical companies.
2) Where do Nitrosamines occur in everyday life?
Nitrosamines can be formed in various ways in foods and other samples. For example, they can be formed through the processing of nitrite-containing meats and fish at high temperatures, especially during grilling or frying. Nitrosamines can also be formed from nitrate and nitrite additives in foods that are used as preservatives. Tobacco smoke is another common source of nitrosamines. Nitrosamines can also be formed in our digestive process due to the acidic stomach environment resulting from a reaction between nitrate and amines.
Nitrosamines can also be found in cosmetics and products made from rubber, such as latex mattresses or balloons. The occurrence in industrially manufactured products is usually subject to strict controls, and if they are contaminated with nitrosamines, this must be indicated. For example, some balloons should only be inflated with a pump for this reason. The intake through food can be reduced by frying at lower temperatures and avoiding nitrate- and nitrite-containing products.
3) How are Nitrosamines measured?
Common screening methods in the pharmaceutical industry for quality control include the separation of substances by HPLC in combination with an electrospray (ESI) or atmospheric pressure chemical ionization (APCI) and a mass spectrometer for the determination of the respective substances. Alternatively, gas chromatography can also be used in combination with EI and a mass spectrometer. However, the very volatile NDMA poses a major challenge for testing laboratories. Some commonly used solvents in the pharmaceutical industry have the same mass as NDMA (so-called isobaric compounds) and are therefore difficult to separate and detect. There is thus a great need for research in this area to protect people’s health.
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