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Calculation of Relative Solubility of Semipolar Solvents by Abraham Solvation Parameter Model for Extractables and Leachables Analysis in Chemical Characterization of Medical Devices

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Abstract

Organic solvents of different polarities (polar, semipolar, and nonpolar) are typically used in extraction studies on medical devices for chemical characterization of their constituents (called extractables or leachables, E/L) potentially exposed to patients during clinical uses per ISO 10993-18 (2020). This study evaluates the difference in solubility of semipolar solvents relative to ethanol for a wide range of E/L in hydrophobicity to help the selection of semipolar solvents for extraction studies. The solvents studied include methanol, ethanol, 1-propanol, 2-propanol (IPA), acetonitrile (ACN), acetone, dioxane, dimethylacetamide (DMA), dimethylformamide (DMF), dimethyl sulfoxide (DMSO), and ethylene glycol. A quantitative analysis of solubility difference (relative to ethanol) among these commonly used semipolar organic solvents over a wide hydrophobicity range based on Abraham general solvation model is presented. These semipolar solvents are also classified according to their solvation properties. The results of the calculation include a slope parameter with respect to hydrophobicity (\({{\text{log}}}_{10}{P}_{\text{O}/\text{W}}\) to describe the solubility ratio changes with an increase in E/L hydrophobicity, and an intercept parameter to describe the relative solubility for more polar E/L compounds. The calculation results are also corroborated by other solvent strength parameters. A recommendation on the rational selection of semipolar solvents in extraction studies is finally provided based on the two parameters, extraction type, and instrumental analysis.

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    Jianwei Li

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Li, J. Calculation of Relative Solubility of Semipolar Solvents by Abraham Solvation Parameter Model for Extractables and Leachables Analysis in Chemical Characterization of Medical Devices. J Solution Chem 51, 816–837 (2022). https://doi.org/10.1007/s10953-022-01173-z

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