Lcms/Ms-Based Analysis of Phthalates in Pharmaceutical Packaging Materials

Abstract

This study aims to investigate the presence and migration of phthalates in pharmaceutical packaging materials using LCMS/MS. Phthalates are widely used as plasticizers in materials such as PVC, PET, and polyethylene. It is known that these substances migrate into pharmaceutical products, which can pose health risks, especially to sensitive populations like infants and pregnant women. It analyzes 50 samples from various packaging types, such as blister packs, plastic bottles, and containers, evaluating the levels of phthalate concentrations and migration. A high degree of migration to the food was found, especially in PVC-based blister packs; higher concentrations of DEHP and DBP were observed in these materials. The results highlight the need for regulatory measures on stricter levels and the introduction of safer, phthalate-free packaging. The findings indicate a significant risk of consumer exposure to phthalates, and hence further research on safer materials and better detection methods is warranted.