Registration Dossier
Registration Dossier
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EC number: 617-349-5 | CAS number: 82543-17-7
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-01-17 to 2002-02-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- 21a-Homo-6 alpha,7 alpha,15 alpha,16 alpha-tetrahydro-bis-3' H-cyclopropa[1',2':6,7;1'',2'':15,16]-5 beta,17 alpha-pregn-20-yne-3 beta,5,17,21a-tetrol
- EC Number:
- 617-349-5
- Cas Number:
- 82543-17-7
- Molecular formula:
- C24 H34 O4
- IUPAC Name:
- 21a-Homo-6 alpha,7 alpha,15 alpha,16 alpha-tetrahydro-bis-3' H-cyclopropa[1',2':6,7;1'',2'':15,16]-5 beta,17 alpha-pregn-20-yne-3 beta,5,17,21a-tetrol
- Test material form:
- solid: bulk
Constituent 1
Results and discussion
Water solubility
- Key result
- Water solubility:
- 1.34 g/L
- Temp.:
- 20 °C
- pH:
- 6.1
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): soluble (1000-10000 mg/L)
- Executive summary:
The water solubility of ZK 34506 was determined using the flask method. The following solubility with 95 % confidence interval of the substance in saturated solution was obtained after equilibration at 20°C and separation from the insoluble residues :
S20°C = 1.34 g/L ± 0.10 g/L
The pH value of the aqueous solution was determined to be 6.1. ZK 34506 can be considered as slightly soluble in accordance with the descriptive term of Ph.Eur. 3rd Edition and USP 24. According X-ray powder diffraction the starting material (batch 28075017) consists of the same solid state form as the insoluble residue.
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