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EC number: 216-703-2 | CAS number: 1644-11-7
Table 1. Summary of PPVE-2 water solubility results (ng/mL) (1)
Time point 1 (Five days)
Time point 2
Time point 3 (Seven days)
Time point 4 (Ten days)
Vial 1 Avg (2)
Vial 2 Avg (2)
Vial 3 Avg (2)
11 (n = 36)
(1) PPVE-2 Solubility Concentration (ng/mL) using EXTERNAL Standard Quantitation. Results are considered accurate to within the calculated analytical method uncertainty for PPVE-2 of 100±37%.
2) Average of triplicate aliquots, number in parentheses are % RSD of the triplicate aliquots (Intra-vial precision).
The water solubility of PPVE-2 was determined according to OPPTS 830.7840 “Water Solubility: Column Elution Method; Shake Flask Method”.
Triplicate test vials were prepared by injecting 100 μl of PPVE-2 into the test vials pre-filled with Milli-Q reagent water to zero-headspace. The vials were incubated at approximately 30°C with shaking at 100 rpm for total of 4 time points (5, 6, 7, and 10 days). At the end of each time point, the vials were centrifuged at a setting of 1000 rpm for at least 15 minutes, then allowed to equilibrate for at least 24 hour at 24.9 – 26.3 °C. Triplicate aliquot of 5 mL of the aqueous solution were removed from the test vial and transferred to a separate vial containing 5 mL of MilliQ water, and analyzed using purge and trap gas chromatography/mass spectrometry (GC/MS). The intra-day average solubility concentration ranged from 2.68 – 2.96 ng/mL (N = 9). The overall average (N=36) was 2.78 ng/mL (RSD = 11%).
This is a guideline study conducted under GLP. Therefore, it is considered reliable without restriction and a key study.
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