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Description of key information

GLP study according to EU testing guideline C.7.
Analytical Development Physical Chemistry, Schering AG, Berlin. Study report No. A05755 (ADP 2001_201), dated 2001-12-20.
Result: The test compound is hydrolytically stable at pH 4, exhibits 9 % decay after 35d at pH 7 and hydrolyses with a half-life of 7.9d at pH9 (at 25°C).

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Additional information

The rate of hydrolysis in aqueous solutions buffered to pH values of 4, 7 and 9 was studied according to EU testing guideline C.7.

No hydrolytic degradation was observed within 5 days at pH 4 at 50 ± 0.1 °C (pretest). Therefore no further testing was required and the compound can be considered to be hydrolytically stable at pH 4 and 25 °C.

At pH 7 a dacay of approx. 9 % was observed after 35d. However, no half-life could be extrapolated due to the low degradation during the observation time.

At pH 9 a half-life of hydrolysis of 7.9d (95% confidence limits 7.7d to 8.1d) was determined.