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EC number: 206-119-6 | CAS number: 302-23-8
Hydrolysis
Administrative data
Link to relevant study record(s)
Description of key information
Experimental study according to EU Method C.7.
General Physical Chemistry, Schering AG, Berlin. Study report M958 (APC 64/97), dated 1997-07-07.
The substance is stable at pH 4 and pH 7. At pH 9 (25°C) a half-life of hydrolysis of 148 days at was determined by extrapolation from measurements at elevated temperatures.
Key value for chemical safety assessment
Additional information
1997-07-07The rate of hydrolysis of hydroxyprogesterone acetate was determined according to EU guideline C.7 at pH 4, 7 and 9.
Less than 10 % of the test substance were degraded at pH 4 and 7 within 5 days at 50 ± 0.1 °C. Therefore no further testing was necessary at pH 4 and 7.
At pH 9, more than 10 % degradation were observed within 5 days at 50 ± 0.1 °C.
Therefore further hydrolysis experiments were necessary at pH 9. Measurements were conducted at two temperatures above 50 °C with replication at the lower of these two temperatures in order to extrapolate from the experimentally determined hydrolysis rate constants at higher temperatures to the rate constant at 25 °C by using the Arrhenius equation and the experimental data.
The rate constants and half-lives at 25 °C are summarized in the following table.
pH |
k [h-1] |
half-life |
|
4 |
- |
stable |
|
7 |
- |
stable |
|
9 |
1.948 · 10-4 |
148 days |
|
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