Registration Dossier
Registration Dossier
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EC number: 200-004-4 | CAS number: 50-03-3
Water solubility
Administrative data
Link to relevant study record(s)
Description of key information
Valid experimental GLP-study using the flask method.
General Physical Chemistry, Schering AG, Berlin, Study report A01509 (APC 60/00), author G. Winter, dated 2000-08-09.
Result: S(20°C) = 6.5 mg/L ± 0.4 mg/L
Key value for chemical safety assessment
- Water solubility:
- 6.5 mg/L
- at the temperature of:
- 20 °C
Additional information
The water solubility of hydrocortisone-21-acetate was determined using the flask method* according to EU Method A.6 at 20°C to be:
S(20°C) = 6.5 mg/L ± 0.4 mg/L
Hydrocortisone-21-acetate can be considered as insoluble in water in accordance with the descriptive term of EP 3 and USP 23. The pH value of the saturated water solutions was determined to be 6.4 ± 0.4
(According to X-ray powder diffraction the starting material and the insoluble residues from water consist of the same solid state form.)
*this is a deviation from the guideline, because for solubilities below 10 mg/L the column elution method should to be used.
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