Screening Analysis of Phthalate Esters and Qualitative Analysis of Other Additives in Medical Supplies Using the Py-GC/MS Screening System

Although phthalate esters are used as plasticizing agents in plastics, there are concerns over their reproductive toxicity. This has led to regulatory restrictions on their use, including a Restriction of Hazardous Substances (RoHS) Directive that added phthalate esters to the list of restricted substances. The phthalate ester DEHP is used widely in blood transfusion bags, blood transfusion tubing, and other medical supplies, and the elution and transfer of DEHP into the contents of medical supplies is viewed as a problem. The use of medical supplies that are free of phthalate esters is recommended in notifications issued by various countries (Japan's Ministry of Health, Labour and Welfare in 2002, USA's FDA in 2002, Europe's EFSA in 2005, and Germany's BfR in 2013).

For some time, Soxhlet extraction-GC/MS and soaking extraction-GC/MS have been used to analyze phthalate esters in medical supplies, but these methods require a series of operations that can take several hours. Py-GC/MS is a new method of screening for phthalate esters that is adopted as part of International Standard IEC 62321-8 in 2017. The Py-GC/MS screening method requires no organic solvents and allows for rapid sample preparation. Shimadzu offers this analysis method in the form of the Py-Screener system.

This Application Data Sheet uses Py-Screener to analyze various medical supplies. A simultaneous Scan/SIM analysis method was paired with Py-Screener's high-speed scanning mode to perform a highly sensitive screening analysis for phthalate esters using SIM and, simultaneously, perform a qualitative analysis of other additives based on Scan information.