Nitrosamine Test Laboratory

Medical Tests

Nitrosamine Test Laboratory

Properties of Nitozamines

Nitrosamines or N-nitrosoamines refer to any molecule containing a nitroso functional group. These molecules are alarming because nitrosamine impurities are likely carcinogenic to humans.

Nitrosamine Test Laboratory

They have proven to be carcinogenic in animal tests, but no consensus has yet been reached as to whether they are canerogenic in humans. Although they are found in some foods, drinking water supplies, cosmetics and personal care products, nitrazmines are not accepted in any way in medicines.

Formation of nitrosamines is generally possible only when secondary or tertiary amines react with nitrous acid. Nitrous acid itself is unstable, but can be formed from nitrites under acid conditions. In particular, contamination from external sources has been identified as the source of nitrosamine content.

Nitrosodimethylamine (NDMA) and nitrosodiethylamine (NDEA) fall into a group classified by the World Health Organization's International Agency for Research on Cancer, possibly human carcinogens. Despite the strength of these impurities, the risk of nitrosamine impurities at the levels found is still very low to cause cancer in humans. For these two nitrosamines, only limited impurity specific toxicity data are available. Due to their structural similarities, several other nitrosamine species are thought to exhibit a toxicological profile such as NDMA and NDEA by international regulators.

In European Union countries, certain manufacturing companies have been asked to review their production processes and, if necessary, modify them in order to minimize nitrosamine impurities practically. A two-year transition period is allowed for these changes. During this transition period, determined intermediate limits are applied to the products. In European Union countries, batches of products exceeding these limits for an individual impurity or batches containing both NDMA and NDEA are not allowed.

Nitrosamine Tests

Low levels of nitrosamine impurities create difficulties for testing. To help test samples, the US Food Drug Administration (FDA) has published several testing methods to consider when determining the nitrosamine content. Similarly, the Council of Europe Network of Official Drug Control Laboratories has published several test methods to be considered when testing for nitrosamines.

A few nitrosamine test methods that are generally performed in advanced laboratories are:

  • Highly selective and sensitive test methods for the quantitation of nitrosamines in pharmaceutical products
  • A rapid test method for measuring nitrosamine compounds with qualitative validation
  • Analysis of genotoxic nitrosamines in active pharmaceutical ingredients
  • A test method for rapid analysis of genotoxic nitrosamines by liquid chromatography-mass spectrometry (HPLC-MS / MS) method
  • Test method for detecting NMDA in pharmaceutical products
  • Liquid chromatography-mass spectrometry (LC-MS / MS) solution for determining nitrosamine impurities
  • Liquid chromatography-high resolution mass spectrometry (LC-HRMS) method for determining the impurity of nitrosamines in drugs
  • Gas chromatography-mass spectrometry (GC / MS) test method

Meanwhile, since 2018, multiple drug products have been recalled because of unacceptable amounts of nitrosamine. To help test these products for the presence of nitrosamines, scientists have developed test methods to detect and measure a large number of different nitrosamines, including gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS) technologies. has developed.

In short, N-nitroso compounds (NOCs) or nitrosamines have led to high profile product recalls many times, whether in the pharmaceutical, food sector or even cosmetic products. Nitrosamines can be carcinogenic and genotoxic and compromise the quality and safety of a product. N-nitrosodimethylamine (NDMA), in particular, is a very potent carcinogen whose traces are widely detected in foods. NOCs potentially enter the food chain in several ways. For example, through, but not limited to, crop protection products used to increase agricultural yields, added sodium or potassium salt to protect certain meats from bacterial contamination, or as a result of direct fire drying in certain foods. Their determination depends on performing detailed and precise tests.

Being a brand of TÜRCERT Teknik Kontrol ve Belgelendirme AŞ and accredited by national and international organizations, EUROLAB closely follows the developments in the world in the field of science and technology and has a strong staff that constantly improves itself. It also uses modern test equipment and applies test methods accepted all over the world.

With this strong infrastructure, EUROLAB also provides nitrosamine testing services for the pharmaceutical, toy and cosmetic industries within the scope of testing and certification services it provides to companies from all sectors.

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