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EC number: -
CAS number: -
Determination of the Abiotic Degradation of FAT 40858/A TE (Hydrolysis as a Function of pH)
In a preliminary test the test item was dissolved
in aqueous solutions buffered at pH 4, 7 and 9 and incubated at
50 ± 0.5 °C for maximum of 5 days.
No significant reduction of the test item
concentration was observed in the samples incubated at pH 4.
In the incubated samples at pH 7 a significant
reduction of the test item concentration was observed.
In the incubated samples at pH 9 the test item
degraded rapidly. No test item related signal could be found in the
freshly prepared samples.
main test was performed to determine the half-life time of FAT 40858/A
TE at pH 7. No main test was performed at pH 4 and pH 9.
Amain test was performed in buffered solutions at
pH 7. The test item was dissolved and incubated at 23°C, 40 °C and
50 °C.The concentration of the test item was determined as a function of
time. The logarithms of the concentration relation (co/ct)
were plotted against the time. A pseudo first order reaction was
assumed. The correlation coefficients were calculated and the reaction
constants and half lifes were calculated from regression data at each
For reaction at pH 7 the Arrhenius relationship was
calculated based on data generated at 23, 40 and 50 °C. Logarithm of the
rate constants were plotted against the reciprocal of the absolute
Following relation was found:
7: ln k = - 11866 * 1/T + 36
UV-chromatograms showed several degradation products as signal eluting
prior to the test item signal. In agreement with the sponsor, no
identification of the metabolites was performed.
The test item is stable at pH 4.
At pH 7, the test item is degraded by hydrolysis.
The half life of reaction at 23 °C was determined to be 23 h at pH 7.
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