Nitrosamines Testing

Nitrosamines belong to a family of carcinogens impurities that are formed by the reaction of secondary amines, amides, carbamates, derivatives of urea with nitrite or other nitrogenous agents with the nitrogen.

Nitrosamines have been classified by the ICH M7(R1) Guideline as Class 1 impurities, “known mutagenic carcinogens,” on the basis of rodent carcinogenicity and mutagenicity data.

The International Agency for Cancer Research (IARC) categorized and labelled them as 2A – Probable Carcinogens depending on data on a number of species studied.

In the ongoing times Nitrosamine testing services are witnessing a huge demand soon after the pharmaceutical drugs like ranitidine, metformin, sartans are identified as possible sources of nitrosamine contamination. Major concern for pharmaceutical industries was after the discovery of genotoxic impurity N- nitrosodimethylamine (NDMA) at low levels in few medicines like Zintak. Traces of carcinogenic NDMA can also be found in some foods and NDMA can be used as an indicator compound for testing of nitrosamines.

Nitrosamines in Food Sector

Reaction of secondary or tertiary amines with a nitrosating agent result in the formation of nitrosamines. Nitrates can also form N-nitrosamines through reduction to nitrites by saliva or enzymes in the intestinal tract.

• The lower molecular weight nitrosamines are derived from alkyl or monocyclic secondary amines and are known as volatile N-nitrosamines.
• High molecular weight and more polar nitrosamines which can be extracted from foods and measured are known as non volatile nitrosamines.
• Third category is the apparent total nitrosamine content (ATNC), which measures combined volatile and non volatile nitrosamines.

Many foods have been analyzed for volatile nitrosamines. Relatively, western foods are found to have more nitrosamines than foods from Asia, Africa. Many nitrosamines are identified in foods and beverages so far.

Frequently Identified Nitrosamine Compounds Encountered in Foods Include:

• N-nitrosodimethylamine
• N-nitroso- diethyl amine (NDEA)
• N-nitrosopiperidine (NPIP)
• N-nitroso- pyrrolidine (NPYR)
• N-nitrososarcosine (NSAR)
• N-nitroso-4-hydroxyproline
• N-nitrosothiazolidine-4-carboxylic acid
• N-nitroso-2-methylthiazolidine-4-carboxylic acid
• N-nitroso-2-hydroxylmethylthiazolidine-4-carboxylic acid
• N-nitrosomethylethylamine (NMEA)
• N-nitrosodipropylamine (NDPA)
• N-nitrosodibutylamine (NDBA)

Nitrosamines are Found in Diverse Food Groups like

• Cured meats
• Non fat dry milk, some cheeses
• Sea food like cooked fish, salt dried fish
• Cooked bacon
• Processed meat
• Alcoholic beverages
• Some fruits and vegetables

Currently Identified Root Causes of Nitrosamines in Foods including but not limited to:

• Use of crop protection products in order to maximize agricultural yields
• Addition of sodium or potassium salt to preserve meat from microbial contamination
• Direct fire drying process in certain foods
• Consumption of nitrates and nitrites in the diet
• Use of contaminated raw materials during manufacturing
• Use of recovered materials like solvents, reagents and catalysts
• Use of contaminated materials and intermediates by nitrosamine.
• Cross-contaminations which may be due to different processes run on the same line
• Degradation processes of starting materials, intermediates and drug substances during storage or for finished products.
• Use of certain packaging materials.

Regulatory Landscape

Both NDMA and NDEA have been classified by national and international regulatory authorities as ‘probable human carcinogens. NDMA in particular is by far the most commonly encountered compound.

In the United States there are limits for NDMA or total nitrosamines in bacon, barley malt, ham and malt beverages, yet there are currently no regulatory limits for N-nitroso compounds (NOC) in foods in the EU.

Manufacturers of crop protection products are required to verify their nitrosamines content in their products to ensure they are within accepted guidelines.

The Food Standards Agency (FSA) approached Premier Analytical Services (PAS) to develop a standard screening method to identify and determine constituent amounts of NOCs in foods formed as a result of manufacturing and processing.

Eurofins is Ready to Serve you

Eurofins is well equipped with all the required equipment to perform analytical tests including, LC MSMS and GC MSMS systems and capable of analyzing nitrosamines in various food categories

The Eurofins Group has built up a network of more than 800 food testing laboratories and competence centres having a strong presence in 47 countries across the globe that perform more than 200 million assays per year to establish the safety, composition, authenticity, origin, traceability and purity of food. The analysis of nitrosamines is quite a bit challenging. Ultra-low levels of these impurities have to be quantified in diverse and complex food, feed and pharmaceutical matrices.

• Eurofins is equipped with all the required equipment to perform analytical tests including, LC MSMS and GC MSMS systems.
• Competence Centres with state-of-the-art equipment such as high-resolution GC, HPLCs, GCMSMS, FTIR, ELISA, HR-MS, GC-MS, HPLC, LC-MS/MS, ICP-MS, Real-time PCR, and NMR systems
• Fast turn-around time (TAT)
• Local contact with a Global Network
• Participation in industry associations and regulatory bodies allowing early advice on potential food scares and legal obligations
• Expert advice - testing schemes, on-site-check for hygiene and allergens, labelling advice and traceability
• Results you can rely on
• International presence

Contact Us