Development and Validation of Gas Chromatography-Triple Quadrupole Mass Spectrometric Method for Quantitative Determination of Regulated Plasticizers in Medical Infusion Sets

Abstract

A method for the quantitative determination of dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), bis(2-ethylhexyl) adipate (DEHA), bis(2-ethylhexyl) phthalate (DEHP), di-n-octyl phthalate (DNOP), dioctyl terephthalate (DOTP), diisononyl phthalate (DINP), and diisodecyl phthalate (DIDP) in medical infusion sets was developed and validated using gas chromatography coupled with triple quadrupole mass spectrometry (GC-MS/MS) in the multiple reaction monitoring (MRM) mode. Solvent extraction with polymer dissolution for sample preparation was employed prior to GC-MS/MS analysis. Average recoveries of the eight target analytes are typically in the range of 91.8–122% with the relative standard deviations of 1.8–17.8%. The limits of quantification (LOQs) of the analytical method were in the ranges of 54.1 to 76.3 ng/g. Analysis using GC-MS/MS provided reliable performance, as well as higher sensitivity and selectivity than GC-MS analysis, especially for the presence of minority plasticizers at different concentrations.

Legacy and Emerging Plasticizers and Stabilizers in PVC Floorings and Implications for Recycling

“…Other products made from PVC, mainly medical devices and toys, have frequently been studied for their plasticizer content (Table S26 in the Supporting Information 1). For PVC medical devices, DEHP has been present in high concentrations (up to 40 wt %) and has only partially been replaced with alternatives (e.g., DiNP, DEHT, DINCH, TEHTM, and ATBC) in recent years. ,,− The use of DEHP in medical devices in the EU had still been specifically authorized until recently, which may explain these findings. , For PVC toys, due to increased regulatory scrutiny in the sector, DEHP and other commonly restricted ortho -phthalates have been replaced with alternatives comparatively early on [mainly with ATBC, DEHT, TXIB, DINCH, ESBO (epoxidized soybean oil, CASRN: 8013-07-8)]. − However, DEHP and other commonly restricted ortho -phthalates are still widely found in many PVC toys across the globe (present in 11 of 118 toys in Switzerland, 89 of 700 in the EU, 17 of 49 in New Zealand, and 1 of 1 in Jordan). − The wide presence of such well-known hazardous substances across a wide range of PVC products points to issues in monitoring and enforcement of existing regulations and may pose a risk of contamination to any PVC product, including flooring, should open-loop recycling occur.…”

“…PVC floorings have been identified as a key source of indoor chemical exposure to hazardous chemicals, especially to multiple ortho -phthalates and are an important source of recycled material. − Despite that, only limited information on the chemical compositions of PVC floorings is publicly available: (1) the SCIP database contains 51 relevant entries (Sheet S11 in the Supporting Information 2), and (2) the few conducted studies have typically had a small sample size and tested a limited number of chemicals. ,− To our knowledge, only one recent study measured many PVC flooring samples, which were from the United States market, using a nontargeted screening approach . Furthermore, various studies focused on other PVC products or indoor dust, which may allow for inferences on the possible chemical content of PVC floorings, but with significant uncertainties. − Plasticizer handbooks suggest large variations across PVC flooring products from different times and regions, as well as across different PVC products. ,− Furthermore, dust samples may also contain plasticizers from other products in the indoor environment. Thus, a research gap remains regarding the chemicals present in a representative selection of PVC floorings in markets other than the United States.…”