STUDIES ON CONTAMINATION OF INTRAVENOUS SOLUTIONS FROM PVC-BAGS WITH DYNAMIC HEADSPACE GC-MS AND LC-DIODE ARRAY TECHNIQUES

The contamination of intravenous solutions from PVC-bags was studied by: (1) dynamic headspace GC-MS of the PVC-material; and (2) screening and identification of the impurities in the intravenous solution by gradient liquid chromatography with a diode array UV-detector (LC-UV-DAD). In the study of the PVC-material, the plastic was heated to 120.degree. C for 5-20 min in an oven, conditions similar to the heat sterilization process of the product. The volatile compounds were transferred into a GC-MS system. The intravenous solution in the PVC-bag was studied by injecting 1 ml of the solution into a gradient LC-UV-DAD system. Both studies show that a wide range of compounds including many unidentified are released from the PVC-material. The following compounds have been identified in a brand of Swedish intravenous solutions in 100 ml PVC-bags: di(2-ethylhexyl)phthalate, mono(2-ethylhexyl)phthalate, phthalic acid, 2-ethylhexanol, phthalide, butylhydroxyanisol, benzaldehyde, benzoic acid and phenol. In solutions from another manufacturer bisphenol-A and cyclohexanon were detected as well. The components were present at .mu.g/l levels except for cyclohexanon which was in the mg/l level.