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Hydrolysis

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Description of key information

The test substance was determined to be hydrolytically stable in sterile aqueous solutions buffered at pH levels of 4, 7, and 9.

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Additional information

A study was conducted to evaluate the hydrolysis of the test substance according to OECD Guideline 111 and US EPA OPPTS Guideline 835.2120, in compliance with GLP. For the preliminary experiment (Tier 1), buffer solutions of pH 4, 7, and 9 were fortified with test substance, and maintained for 5 d at a measured temperature range of 49.86 to 50.04 °C. Samples were analyzed by HPLC for the radioactive test substance at initiation (Day 0) and termination (Day 5). No degradation was observed after 5 d at pH 4, 7, and 9 at 50°C. The hydrolytic stability in buffer solutions was not pH dependent. Based on the findings of the study, the test substance was determined to be hydrolytically stable in sterile aqueous solutions buffered at pH levels of 4, 7, and 9 (Elliott T, 2012).