Article Figures & Data
Figures
- Figure 1
ETO levels found in water test liquid incubated in ETO-sterilized vials as a function of temperature and time. Measured data points (symbols) were fit (lines) with the kinetic model described in the text according to the solution of eqs 1 and 2. The fits shown were obtained with Ci fixed at 21μg/mL (see text).
- Figure 2
Arrhenius plot of parameter values obtained from fitting the kinetic data in Figure 1: mass transfer coefficient (KD, open circles) and reaction rate constant (k, squares).
- Figure 3
ETO concentrations (μg/mL) in test solutions as a function of pH. All vial samples were incubated at 37 °C for 1 week.
- Figure 4
Sodium chloride effects on accumulated ETO levels after incubation of 2.0 mL of test liquid at 37 °C for 1 week.
- Figure 5
ETO modification of methionine residue in IgG1. (a) Product-ion spectra of the ESI-produced [M+2H]2+ ions of unmodified peptide DTLMISR with m/z of 418.2 from IgG1. (b) Product-ion spectra of the ESI-produced [M+2H]2+ ions of ETO-modified peptide of DTLMETOISR with m/z of 440.2 from IgG1. (c) MS3 mass spectra of the most abundant doubly charged ion of [M-92]2+ with m/z of 394.4 from mass spectrum of panel b. A scheme summarizing the observed fragment ions from each mass spectrum is shown on the right for each panel.
Tables
Time (days) 5 °C 25 °C 37 °C 45 °C 0.25 0.08 0.19 0.35 0.45 1 0.20 0.71 1.30 1.67 2 0.35 1.32 2.26 2.73 3 0.48 1.87 3.00 3.26 7 1.12 3.84 4.22 3.50 10 1.53 4.62 4.26 2.96 14 2.24 5.76 4.39 2.61 21 2.37 4.98 2.66 1.49 28 3.31 5.55 2.64 1.20 90 7.08 2.85 0.45 0.03 All samples were filled with 2 mL of water and stored at 5, 25, 37, and 45 °C. The residual ETO was determined at each time point by using the HS-GC/FID method.
- TABLE II
ETO concentration and total accumulated amount in solution at different container fill volume
Water fill volume (mL) ETO Concentration (μg/mL) ETO Amount (μg) 0.5 12.22 6.1 1.0 8.52 8.5 1.5 4.26 6.4 2.0 3.35 6.7 Incubation was for one week at 37 °C.
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