Determination of Trace Nitrosamines in Plastic Pharmaceutical Packaging Materials

Area of Science:

• Pharmaceutical Science
• Analytical Chemistry
• Materials Science

Background:

• Nitrosamines are probable or possible human carcinogens, posing risks even at nanogram per liter concentrations.
• Large Volume Parenteral (LVP) products face stringent regulatory scrutiny due to high volumes and low intake limits.
• Elastomer materials and, recently, infusion bags have been identified as sources of concern for nitrosamine contamination.

Purpose of the Study:

• To investigate the presence of nitrosamines in plastic materials intended for LVP packaging.
• To assess the significance of nitrosamine contamination in the context of raw material qualification for LVP products.

Main Methods:

• Analysis of over 300 batches of plastic materials, including granules and films, used in LVP packaging.
• Trace-level detection of nitrosamines using sensitive analytical techniques.

Main Results:

• Trace levels of nitrosamines, in the nanogram per liter (ng/L) scale, were detected in several plastic granules and films.
• The findings confirm the potential for nitrosamine contamination in materials used for LVP manufacturing.

Conclusions:

• Nitrosamine profiling is crucial during the raw material qualification process for LVP products.
• Ensuring the quality and safety of LVP products requires rigorous testing of packaging materials for contaminants like nitrosamines.