Article Figures & Data
Figures
- Figure 1
Extraction trends of polar extractables.
- Figure 2
Extraction trends of acidic and basic extractables. MDA, 4-4-Methylenedianiline: Myristic Acid.
- Figure 3
Extraction trends of mid-polar extractables. BPA, bisphenol A; DME, Bisphenol A Dimethyl ether; ME, Bisphenol A Monomethyl ether.
- Figure 4
Extraction trends of non-polar extractables. TOTM, Trioctyltrimellitate.
- Figure 5
Extraction trend of polymeric extractable (Note that blue indicates that the value was less than this level in the indicated extraction solvent). PVP, polyvinylpyrrolidone.
Tables
Device Primary Materials of Construction Study Purpose Hemodialyzer Polycarbonate, Polysulfone, Polyurethane, Silicone Comparison of target leachables in blood, saline, and ethanol/water mixtures
Solvent composition measurementBloodline tubing set Plasticized PVC, Acrylonitrile butadiene styrene (ABS), Nylon Nasal Pillow Polydimethylsiloxane Solvent composition measurement Ostomy skin barrier Ethylene vinyl acetate, Polyisoprene Balloon wedge pressure catheter Polyurethane, Polyethylene, Polyisoprene Urethral stent Poly(ethylene:propylene) PVC, polyvinyl chloride.
Analyte CAS RN Notable Chemical Properties Analytical Method for Quantitation Signal Caprolactam 105-60-2 Highly polar (LogP −0.1) LC-MS MRM
(114.1–>42.2)4-4-Methylenedianiline 101-77-9 Basic, polar (LogP 1.6) LC-MS MRM
(199.0–>106.1)Bisphenol A
Monomethyl ether-Bisphenol A
Dimethyl ether-Bisphenol A80-05-7
16530-58-8
1568-83-8Mid-polar (LogP 3.1, 3.4, 3.7, respectively) LC-FLD FLD (Ex = 225 nm; Em = 310 nm) Di-(2-ethylhexyl) phthalate 117-81-7 Non-polar (LogP 7.6) LC-UV DAD (210 nm) Trioctyltrimellitate 3319-31-1 Highly non-polar (LogP 11.6) LC-UV DAD (210 nm) Cyclohexanone 108-94-1 Polar (LogP 0.8), volatile GC-MS SIM
98.0 uMyristic acid 544-63-8 Acidic, Mid-polar (LogP 5.3) LC-MS SIM
272.2 uPolyvinylpyrrolidone 9003-39-8 Polymer GPC DAD
226 nmDAD, diode array detector; FLD, fluorescence detector; GC-MS, gas chromatography with mass spectrometry; GPC, gel permeation chromatography; LC-FLD, liquid chromatography with a fluorescence detector; LC-MS, liquid chromatography with mass spectrometry; LC-UV, liquid chromatography with ultraviolet detection; MRM, multiple reaction monitoring; SIM, single ion monitoring.
Targeted Analyte Concentration of Analyte (μg/Device) Blood Saline 10% Ethanol 20% Ethanol 40% Ethanol 70% Ethanol Caprolactam 27.34 ± 0.83 21.48 ± 0.73 24.18 ± 0.17 24.68 ± 1.71 35.04 ± 1.92 31.10 ± 1.29 4-4-Methylenedianiline1 0.63 ± 0.071 <0.10 2.17 ± 0.26 4.88 ± 0.94 21.7 ± 0.99 89.37 ± 10.00 Bisphenol A <10 <10 <10 0.8 ± 0.2 28.8 ± 4.7 50.5 ± 5.5 Bisphenol A
Monomethyl ether<10 <10 <10 <10 4.9 ± 0.6 7.6 ± 0.8 Bisphenol A
Dimethyl ether<10 <10 <10 <10 11.8 ± 1.9 296.2 ± 68.2 Di-(2-ethylhexyl) phthalate <500 <100 <100 <100 <100 1161 ± 389 Trioctyltrimellitate <500 <100 <100 <100 <100 3631 ± 381 Cyclohexanone <20 30 ± 5 154 ± 8 140 ± 45 269 ± 72 243 ± 31 Myristic acid *elevated in background 1.43 ± 0.17 3.04 ± 0.36 5.21 ± 1.29 55.02 ± 6.93 126.18 ± 15.88 Polyvinylpyrrolidone2 <35 37.3 ± 6.3 43.4 ± 9.6 26.9 ± 6.2 19.6 ± 5.9 5.9 ± 1.1 - TABLE IV
Measured Solvent Composition of Ethanol/Water Mixtures Before and After Extraction
Sample Type 20% Ethanol in Water 50% Ethanol in Water 70% Ethanol in Water Refrigerated stock solution 19.8% 48.6% 66.9% Heated stock solution 19.4% 47.6% 67.3% Nasal pillow 21.4% 49.4% 70.5% Ostomy skin barrier 22.8% 49.7% 70.3% Balloon catheter 20.2% 49.9% 69.7% Urethral stent 19.4% 48.0% 69.1% Average of duplicate measurements of a single sample preparation.
- TABLE V
Measured Solvent Composition of Ethanol/Water Mixtures After Dialyzer and Tubing Set Extraction
Sample Type 10% Ethanol in Water 20% Ethanol in Water 40% Ethanol in Water 70% Ethanol in Water Hemodialyzer and bloodline tubing set recirculation extraction 9.9% 18.4% 37.4% 65.6% Samples were analyzed in triplicate and the average value reported.
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