Division Circumstances in which required

The hydrolysis rate of purified active substances shall be determined and reported at 20 °C or 25 °C. Studies on hydrolytic degradation shall also be performed for degradation and reaction products which account at any time for more than 10 % of the amount of active substance added in the hydrolysis study, unless sufficient information on their degradation is available from the test performed with the active substance. No additional hydrolysis information on degradates shall be required if they are considered to be stable in water.