Abstract
To compare the analytical quality characteristics of currently available CE-marked silicone oils used as ocular endotamponades in vitreoretinal surgery. Thirty-four samples of 12 brands were analysed. To assess the quality characteristics of silicone oils, we measured the oligosiloxane content and polydispersity, widely accepted as purity parameters. UV-active substances (> 220nm) were analysed to draw conclusions about the integrity of primary packaging components. We identified significant differences in the impurity profiles of the products tested, which revealed oligosiloxane contents ranging from < 0.1 to 491ppm, polydispersity ranging from 1.6 to 3.0 and UV-active substances (> 220nm) ranging from 0.2 to 3.8AU. The quality characteristics of the analysed silicone oils vary significantly not only among different brands but also among batches of the same manufacturer. Manufacturers should communicate the purity and quality characteristics of their products in an understandable and clear manner. This involves providing a complete certificate of analysis with special focus on quality characteristics, to enable the vitreoretinal surgeon to differentiate between the effects of the silicone oil itself and those of impurities.
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