N-Nitrosodiisopropylamines (NDIPA) are organic chemical compounds used for testing and analysis purposes only. They are not intended for administration to humans or animals and cannot be used to diagnose, treat or cure any disease.
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Previously, nitrosamine impurities such as N-Nitrosodiethylamine (NDEA), N-Nitrosodiisopropylamine (NDIPA), N-Nitrosoethylisopropylamine (NEIPA) and N-Nitrosodibutylamine (NDBA) were used in the manufacture of pharmaceuticals. However, pharmaceutical products using APIs containing these compounds have been recalled worldwide. Today it is no longer used in the manufacture of drugs.
N-nitrosamines contain the nitroso functional group, and the World Health Organization (WHO) has identified most nitrosamines as genotoxic to animals and possibly carcinogenic to humans. Research by pharmaceutical companies has revealed that nitrosamines are formed during the production process under acidic conditions through the reaction of secondary or tertiary amines and nitrites. Therefore, the European Pharmacopoeia Commission established a limit of 30 ppm for nitrosamines in pharmaceutical active ingredients (APIs) at the end of 2020.
Measurement at these limits requires the use of highly sensitive and highly selective analytical testing methods. Most tests use either the gas chromatography - mass spectrometry (GC-MS) method or the liquid chromatography - mass spectrometry (HPLC-MS) method. Another challenge with these tests is the variety of nitrosamines, APIs, and formulations that require specially adapted methods for impurity testing.
In general, nitrosamines are impurities found in a wide variety of cosmetic product ingredients, including N-Nitrosodiethylamine (NDEA). International organizations classify nitrosamines as toxic to more animal species than any other chemical carcinogen category. Although common in cosmetics, nitrosamines are not listed on product labels because they are impurities, and it is generally recommended to avoid them. Nevertheless, they are found in almost every type of personal care product. Nitrosamines are formed when certain compounds, such as N-Nitrosodiethylamine (NDEA), are used in products along with preservatives that can convert to nitrates. As these compounds break down over time, they can recombine into nitrosamines. For example, NDEA are additives commonly used in cosmetics to adjust pH levels or act as wetting agents.
Our organization also provides N-Nitrosodiisopropylamine (NDIPA) testing services 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.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
