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EC number: 200-004-4 | CAS number: 50-03-3
Hydrolysis
Administrative data
Link to relevant study record(s)
Description of key information
The hydrolytic stability of hydrocortisone-21-acetate was estimated on basis of the hydrolytic behaviour of a structurally similar compound.
Analytical Development Physical Chemistry, Schering AG, Berlin. Study report A08865 (ADP 2002_125), author M. Tschampel, dated 2002-06-18.
Result: Hydrocortisone-21-acetate can be expected to be hydrolytically stable at pH4 and to hydrolyze with half-lives of in the range of 50 to 120 d at pH 7 and in the range of 34 to 42 days at pH 9 (at 25°C).
Key value for chemical safety assessment
Additional information
The only hydrolyzable functional group in hydrocortisone-21-acetate is the ester function in the side chain at position17. The hydrolytic behaviour is expected to be similar to that of the structurally closely related compounds 21-Acetoxy-6 beta-fluoro-16 alpha-methyl -4-pregnene-3,20-dione / 21-Acetoxy-6 alpha-fluoro-16 alpha-methyl -4-pregnene-3,20-dione, which differ slightly in the steroid moiety, only. The rate of hydrolysis of of these compounds was determined according to EC guideline C.7 at pH 4, 7 and 9. This compounds were found to be hydrolytically stable at pH 4 and to hydrolyze with half-lives of in the range of 50 to 120 days at pH 7 and in the range of 34 to 42 days at pH 9 (at 25°C), see following table:
pH |
isomer |
half-life
|
95 % confidence intervals for half-life
|
4 |
6-a |
stable* |
- |
4 |
6-ß |
stable* |
- |
7 |
6-a |
109 d |
101 – 118 d |
7 |
6-ß |
57 d |
52 – 62 d |
9 |
6-a |
39.6 h |
37.9 – 41.5 h |
9 |
6-ß |
36.8 h |
34.7 – 39.1 h |
* criterion according to EC testing guideline C.7: half-life > 1 year at 25 °C
Comparable results are to be expected for hydrocortisone-21-acetate.
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