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EC number: 813-789-9
CAS number: 152873-67-1
Determination of the Water Solubility at pH 7 by the Shake Flask Method
This study was based on the procedures
indicated by the following internationally recognized documents:
OECD Guidelines for Testing of Chemicals,
Guideline No.105, ”Water Solubility”; adopted July 27, 1995
Commission Regulation (EC) No 260/2014,
Annex, Part A, Methods for the determination of physico-chemicals
properties, A6 "Water Solubility", January 2014
Product Properties Test Guideline of the
United States Environment Protection Agency (EPA), OPPTS 830.7840 Water
Solubility: Column Elution Method; Shake Flask Method, March 1998
Purpose: The purpose of this study was to
evaluate the solubility of the test item in water at pH 7 which is
specified by the saturation mass concentration of the test item in water
at a specified temperature.
The water solubility of the test item was
determined using the shake flask method. The saturation mass
concentrations of the test item were determined using UPLC / UV-VIS. The
preliminary test with pure water and water buffered at pH 4, 7 and 9
showed that the pH-dependency is neglectable, therefore the main test
was performed at pH 7.
The results showed no tendency to increase
and met all validity criteria, therefore the study is considered to be
valid. Corresponding to the analyses the water solubility at pH 7 was
determined to be 260 g/L at 20 °C.
study is classified acceptable and satisfies the guideline requirements
for water solubility studies.
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