Benchmarking different brands of perfluorocarbon liquids

Toxicity Threshold of Perfluorocarbon Liquids for Intraocular Use: Dose–Response Assessment of In Vitro Cytotoxicity of Possible Contaminants

“…The risk of presence or appearance of potentially toxic substances in PFCL-based medical devices used as vitreous tamponades needs to be excluded by the manufacturers using accurate analytical methods and adequate safety criteria for their clinical use. 6 - 8 , 11 , 18 , 21 …”

“…The different physical-chemical methods such as gas chromatography coupled with mass spectroscopy, nuclear magnetic resonance (NMR), ultraviolet-spectrophotometry and ion selective potentiometry 10 , 13 , 21 may be used to detect and quantify the presence of specific potentially hazardous substances. However, these methods do not provide any information on their toxicity.…”

“…The risk of presence or appearance of potentially toxic substances in PFCL-based medical devices used as vitreous tamponades needs to be excluded by the manufacturers using accurate analytical methods and adequate safety criteria for their clinical use. [6][7][8]11,18,21 The different physical-chemical methods such as gas chromatography coupled with mass spectroscopy, nuclear magnetic resonance (NMR), ultravioletspectrophotometry and ion selective potentiometry 10,13,21 may be used to detect and quantify the presence of specific potentially hazardous substances. However, these methods do not provide any information on their toxicity.…”

“…The toxicity of PFCLs is often caused by incomplete fluorination of hydrocarbons, the major impurities in PFCLs contain residual hydrogen-containing compounds and unsaturated carbon bonds. [20][21][22] Chang et al 7 determined hydrogen content in PFO by NMR spectroscopy. Because the safety threshold of protonated impurity in PFCL for intraocular use was unknown, they sought to obtain liquid of the highest grade corresponding to protonated impurity content < 0.1 ppm and equivalent to the detection limit of the method.…”

“…Menz et al 10 used physical-chemical determination of partially hydrogenated perfluoroalkanes through the ion-selective potentiometry after digestion of perfluorocarbon liquid. 13,21 This analysis determines the socalled H-value, defined as the ppm content of reactive partially hydrogenated perfluoroalkanes and to which an H-value <10 ppm was attributed as the safety threshold by Menz et al 10 However, the ion-selective potentiometry does not detect toxic substances without a specific hydrogen-fluoride-containing compounds such as the hydroxyl impurities identified in the toxic batches of PFCL. 8,11,17 Our study showed that in vitro cytotoxicity test can provide direct information on cytotoxicity of impurities contained in PFCLs, independently from substances identification and quantification.…”