Registration Dossier
Registration Dossier
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EC number: 617-347-4 | CAS number: 82543-16-6
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-12-06 to 2001-12-17
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- No version available
- GLP compliance:
- yes
- Type of method:
- flask method
Test material
- Reference substance name:
- 3 beta,5-Dihydroxy-6 beta,7 beta;15 beta,16 beta-dimethylene-5 beta-androstan-17-one
- EC Number:
- 617-347-4
- Cas Number:
- 82543-16-6
- Molecular formula:
- C21 H30 O3
- IUPAC Name:
- 3 beta,5-Dihydroxy-6 beta,7 beta;15 beta,16 beta-dimethylene-5 beta-androstan-17-one
- Test material form:
- solid
Constituent 1
Results and discussion
Water solubility
- Key result
- Water solubility:
- 0.149 g/L
- Temp.:
- 20 °C
- pH:
- 6.2
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): moderately soluble (100-1000 mg/L)
- Executive summary:
The water solubility of ZK 34517 was determined using the flask method. The following solubility of the substance in saturated solution was obtained after equilibration at 20 °C and separation from the insoluble residues :
S20°C = 0.149 g/L ± 0.003 g/L.
The pH value of the aqueous solution was determined to be 6.2. ZK 34517 can be considered as very slightly soluble in accordance with the descriptive term of Ph.Eur., 3rd Edition and USP 24. According to X-ray powder diffraction the starting material (batch 28072009) consists of the same solid state form as the insoluble residue.
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