Abstract:
OBJECTIVE To investigate the safety of polypropylene infusion bottle and it's compatibility with the Ganciclovir and Sodium Chloride injection.
METHODS The determination methods of antioxidants and antacids were established; the interaction on injection and packing materials were measured through extraction, migration and adsorption test; and the compatibility was evaluated by the reported toxicology research data of additives.
RESULTS The antioxidants and their oxides and/or degradation products were determined by HPLC, and their reporting thresholds were 0.098-0.98 μg·mL
-1. The contents of Mg and Al in the antacids were determined by AAS, and their reporting thresholds were 0.025-0.1 μg·mL
-1. While the analytical evaluation thresholds of each additives were 0.83-117 μg·mL
-1, it was higher than their respective reporting threshold. In the extraction and migration experiments, no additive and obvious adsorption of API were found in the injection.
CONCLUSION The extracts of polypropylene infusion bottles are lower than their permitted daily exposure. The packing material does not adsorb Ganciclovir and Sodium Chloride injection and has good compatibility.