Nitrosamine impurities occur at microgram levels. Therefore, sensitive and specific analytical test methods are applied for their detection. The amount of impurities detected in pharmaceutical products can vary widely depending on who is doing the testing, the manufacturer of the drug, and the specific batch being tested.
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Gas chromatography (GC) method combined with thermal energy analysis or mass spectrometry (MS) is used to detect heat sensitive nitrosamine impurities. Gas chromatography method combined with mass spectrometry is known to have high selectivity and sensitivity. Another option applied in these analyzes is the use of thermal energy analysis, mass spectrometry (MS) or liquid chromatography (LC) combined with ultraviolet light (UV). Liquid chromatography is used for both volatile and non-volatile nitrosamines. High-performance liquid chromatography and ultraviolet light aid in the analysis of low-dose drugs.
Sartans were the first class of drugs in which nitrosamine impurities were detected. After a while, other drugs were also found to contain NDMA and NDEA. Upon the discovery of nitrosamine impurities in commonly prescribed drugs, N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA) and N-methyl-4-aminobutyric acid in these products were determined by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Limitations have been placed on various nitrosamine impurities, including acid (NMBA). N-Nitrosomethylphenylamine (NMPA) impurity is also among these restricted compounds.
The scientific understanding of how nitrosamines are formed and removed is still a developing field. Therefore, pharmaceutical, cosmetic, and food manufacturers, in particular, need advanced laboratory testing to address and assess risks. This requires reviewing how drugs are chemically synthesized, examining the materials used to produce the active ingredient and the formulated drug product, and implementing controls where appropriate to minimize the risk from nitrosamines. Meanwhile, regulatory bodies regularly publish guidelines on the possible root causes of nitrosamine formation.
Our organization also provides N-Nitrosomethylphenylamine (NMPA) 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.
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