Determination of Trace Nitrosamines in Plastic Pharmaceutical Packaging Materials

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.