PURPOSE: To compare the analytical quality characteristics of currently available CE-marked perfluorocarbon liquids (PFCL) applied intraoperatively during vitreoretinal surgery. METHODS: Twenty-one samples of 8 brands of perfluorooctane (PFO) and 25 samples of 13 brands of perfluorodecalin (PFD) were analysed. Gas chromatography coupled with mass spectroscopy (GC/MS) was used to determine the content of the main product. The amount of reactive and underfluorinated impurities was analysed and expressed as an H-value using fluoride selective potentiometry after a chemical transformation reaction to detect impurities that triggered both acute and latent toxic effects. UV-active substances were determined in order to draw conclusions on the integrity of primary packaging components. Moreover, we controlled for any 1H-PFO contamination in PFO, as it is known to modify PFO's surface characteristics. RESULTS: Significant differences in the tested products' purity profiles were detected. The PFO batches revealed H-values ranging from < 10 to 1230 ppm and 1H-PFO concentrations ranging from < 1 to 376 ppm. Leachable substances from packaging components cause UV absorption in the 0.1 to > 3 AU range. The PFD batches revealed H-values ranging from < 10 to 70 ppm and leachables from packaging components resulting in absorbances in the 0 AU to 3.2 AU range. CONCLUSION: The quality characteristics of the analysed PFCL vary significantly, not only among different brands but among batches from the same manufacturer as well. Manufacturers should communicate the purity of their products in an understandable and clear manner. This would require providing a complete certificate of analysis focussing especially on quality characteristics to enable vitreoretinal surgeons to differentiate between the effects from the PFCL itself and those from impurities.
PURPOSE: To compare the analytical quality characteristics of currently available CE-marked perfluorocarbon liquids (PFCL) applied intraoperatively during vitreoretinal surgery. METHODS: Twenty-one samples of 8 brands of perfluorooctane (PFO) and 25 samples of 13 brands of perfluorodecalin (PFD) were analysed. Gas chromatography coupled with mass spectroscopy (GC/MS) was used to determine the content of the main product. The amount of reactive and underfluorinated impurities was analysed and expressed as an H-value using fluoride selective potentiometry after a chemical transformation reaction to detect impurities that triggered both acute and latent toxic effects. UV-active substances were determined in order to draw conclusions on the integrity of primary packaging components. Moreover, we controlled for any 1H-PFO contamination in PFO, as it is known to modify PFO's surface characteristics. RESULTS: Significant differences in the tested products' purity profiles were detected. The PFO batches revealed H-values ranging from < 10 to 1230 ppm and 1H-PFO concentrations ranging from < 1 to 376 ppm. Leachable substances from packaging components cause UV absorption in the 0.1 to > 3 AU range. The PFD batches revealed H-values ranging from < 10 to 70 ppm and leachables from packaging components resulting in absorbances in the 0 AU to 3.2 AU range. CONCLUSION: The quality characteristics of the analysed PFCL vary significantly, not only among different brands but among batches from the same manufacturer as well. Manufacturers should communicate the purity of their products in an understandable and clear manner. This would require providing a complete certificate of analysis focussing especially on quality characteristics to enable vitreoretinal surgeons to differentiate between the effects from the PFCL itself and those from impurities.
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Keywords:
Heavy liquids; Impurity; Retina; Vitrectomy