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HPLC was employed to determine the Test Item E Stage 3 Intermediate. The recovery test in buffer solution used two concentrations, 2mg/L and 50 mg/L. The mean recovery rate was in the range 87.8- 106.1% with RSD in the range of 0.6 -4.4%. The analytical method used met the quality criteria. The hydrolysis rate at pH 4.0, 7.0 and 9.0 were all less than 10% on the 5th day at 50oC ± 0.5oC so the definitive test was terminated.
The test item E Stage 3 Intermediate is hydrolytically stable. The DT50 cannot be calculated but is estimated to be >1 year at 2.5oC based on Test Guideline MEP 111.
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