PDA journal of pharmaceutical science and technology · 2026
Determination of Trace Nitrosamines in Plastic Pharmaceutical Packaging Materials.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
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Jost Lukas, Sprau Frank, Thörner Lukas, Wan Annie, Trujillo Payden, Zhou Shiwei, Shaner Lucas, Li Ethan, Sechin Bilig, Gläser Lars, Young David, Kampeis Percy, Yang Weichun
Аннотация
Nitrosamines are classified as probable (IARC Group 2 A) or possible (IARC Group 2B) human carcinogens, capable of inducing tumors even at very low concentrations (nanogram per liter levels). Regulatory considerations specifically affect large volume parenteral (LVP) products due to the high application volume combined with very low allowable intake limits. These compounds have already attracted significant attention for elastomer materials like rubber. A recent FDA communication highlighted the particular importance of infusion bags, given their unique nature. In this study, over 300 batches of plastic materials, used for LVP packaging, were tested, and trace levels of nitrosamines at nanogram per liter scale were detected in several plastic granules and films. These results indicated the importance of nitrosamine profiling during raw material qualifications for LVP products.