Test Substance

Purified Water (Ultra-pure water)
 

Objective
 

To evaluate the hydrolysis rate of the test substance at various pH levels and temperatures. In this study, a 1 M stock solution of the test substance is prepared using ultra-pure water and subsequently spiked into buffer solutions of different pH values.

A preliminary test (Tier 1) is conducted at a constant temperature of 50°C across three pH levels to observe the hydrolytic behavior. Appropriate analytical methods are employed to identify hydrolysis products and establish the relationship between the degradation of the parent substance and the formation of its metabolites. The test is monitored for a maximum of 30 days or until 90% of the test substance has hydrolyzed.

The correlation between pH and hydrolysis rate is determined by plotting the logarithm of concentration versus time for both the test substance and its hydrolysis products. These plots are utilized to calculate the half-life or the  (Disappearance Time for 50% of the substance) of the test substance.


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