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KMID : 1142220210160010063
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 1 p.63 ~ p.93
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Analytical Methods of N-Nitrosamines in Pharmaceuticals
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Lee Ji-Youn
Seo Su-Min
Joung Sun-Koung
Han Sang-Beom
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Abstract
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N-Nitrosamines, which have long received attention in the fields of food hygiene and environmental health, have been detected in several drug substances and drug products. Nitrosamine impurities were continuously detected in a number of pharmaceuticals such as Ranitidine, Nizatidine, and Metformin, starting with angiotensin receptor blockers such as valsartan. As a result, domestic and foreign regulatory agencies took measures to inspect the collection, discontinue manufacturing, and recall the drug, and the controversy over the safety of the drug has been raised for the past three years. In this paper, various official compendial and academic papers reported on the analysis method of Nitrosamine impurities among pharmaceuticals are summarized by classifying them into Sartans, Ranitidine·Nizatidine, and Metformin drugs. The advantages and disadvantages of liquid chromatographymass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS), which are mainly used, were reviewed. In addition, the pre-treatment method for the analysis of Nitrosamines among pharmaceuticals, the cause of its formation, and precautions are also summarized
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KEYWORD
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Nitrosamines, Sartans, Ranitidine, Nizatidine, Metformin, Mass spectrometry
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