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Liquid chromatography with a mass spectrometer is used to determine the hydrolysis rate of the test item.


With LC/MS a direct method is used t0 measure the amounts of Mono- and Diester, which will remain after incubation in case of hydrolysis. No decreases > 10% of Mono- and Diester have been detected at pH 4, 7 and 9. At pH 2 the expected hydrolysis takes place.


Therefore the hydrolysis rate of the test item is


Hydrolysis rate: no hydrolysis observed at pH 4, 7 and 9

Hydrolysis observed > 10% at PH 2

T ½ (25°C) > 1 year for pH 4, 7 and 9