Study of extractables and leachables of non ‐polyvinyl chloride soft infusion bags from different batches by analytical assessment threshold screening

This study utilized ultra-high-performance liquid chromatography combined with quadrupole time-of-flight mass spectrometry and gas chromatography –mass spectrometry techniques to analyze multiple batches of non-polyvinyl chloride (PVC) soft bags exposed to three extractants. Multivariate statistics were used to identify extractable changes between batches and performed a risk assessment. AbstractThis study utilized ultra-high-performance liquid chromatography combined with quadrupole time-of-flight mass spectrometry and gas chromatography –mass spectrometry techniques to analyze multiple batches of non-polyvinyl chloride (PVC) soft bags exposed to three extractants. Based on an established library of relative response factors for more than 30 different polymer additives, analytical evaluation thresholds for large volume injectables were determined, and 30 extractables were screened and (semi-)quantitatively analyzed. To identify variations in extractables between batches, multivariate statistical methods such as principal component analysis, heat map analysis, and hierarchical cluster analysis were employed. Additionally, a c omprehensive risk assessment of extractables and a biosafety assessment of leachables were conducted. The results of the study revealed that the concentrations of two extractables exceeded the established safety threshold. Moreover, one of these extractables was deemed to pose a mutagenic risk based on the consistent findings of two (Q)SAR software t...
Source: Packaging Technology and Science - Category: Food Science Authors: Tags: RESEARCH ARTICLE Source Type: research