Monitoring of potential endocrine disruptor plastic additives by UHPLC-HRMS in prefilled plastic packaging in a hospital setting

5 October 2022

W. Bello1,2,3,4, J. Pezzatti1, S. Rudaz3,4, and F. Sadeghipour1,2,3,4
1 Service of Pharmacy, Lausanne University Hospital
2 Center for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and University of Lausanne
3 School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland
4 Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, Geneva, Switzerland

Medical devices (MDs) are strictly monitored to meet the legal requirements according to United States and European Pharmacopoeias, whose specifications are based on toxicology calculations. However, there is an ongoing lack of safety control measures when it comes to identifying and determining leachable endocrine disruptors compounds (EDC) in the health sector. In a hospital setting, neonates and children may be the most sensitive populations when exposed to these substances, due to their premature and growing features. Long-term parenteral treatments, such as total parenteral nutrition and anti-infective, could lead them to develop probable latent health effects.

Materials and Method
Our Quality Control laboratory has developed a highly sensitive analytical method using ultra high pressure liquid chromatography hyphenated to high-resolution mass spectrometry (UHPLC-HRMS) for the screening and identification of more than 7 categories of leachables, i.e. more than 300 compounds. These are enabled thanks to the use of retention time, exact mass (including isotopic pattern) and MS/MS spectra. An innovative set-up, based on post-column infusion (PCI) using 2% ammonium hydroxide in methanol, was considered to boost signal intensity of the analytes. For the application of this method, a pharmacy-prepared prefilled polypropylene syringe containing vancomycin (5 mg/mL) in NaCl 0.9% was selected due to its regular use in the treatment of gastro-intestinal infections.

Our method enabled the identification of 17 plastic additives and potential EDCs, ranging from an estimated concentration of 0.04 to 8.5 ng/mL, involving different categories such as plasticisers, antioxidants, photo-stabilisers and anti-microbials. Non-intentionally added substances such as bisphenol A was identified at less than 10 ng/mL due to possible industrial manufacturing process contaminations. Due to the rapid changing nature of neonates and children, their hormonal receptors could possess very high affinities for EDCs at very low concentration levels.

In conclusion, a screening method was developed by using PCI-UHPLC-HRMS to monitor EDCs in hospital MDs, enabling the identification and estimated concentration of 17 potential EDCs in a vancomycin prefilled syringe. Due to the lacking toxicology information, more studies are required for further EDC assessment.

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