Registration Dossier
Registration Dossier
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EC number: 404-520-2 | CAS number: 139893-43-9 SIMVASTATIN AMMONIUM SALT
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18th August 2010 to 26th November 2010
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- GLP compliance:
- yes
- Type of method:
- column elution method
- Specific details on test material used for the study:
- Simvastatin ammonium salt
- Key result
- Water solubility:
- 13.1 g/L
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 25 000 mg/L
- Incubation duration:
- 24 h
- Temp.:
- 20 °C
- pH:
- 9
- Remarks on result:
- completely miscible
- Key result
- Water solubility:
- 9.2
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 17 700 mg/L
- Incubation duration:
- 24 h
- Temp.:
- 20 °C
- pH:
- 7
- Remarks on result:
- completely miscible
- Key result
- Water solubility:
- ca. 0.069 g/L
- Conc. based on:
- test mat.
- Loading of aqueous phase:
- 500 mg/L
- Incubation duration:
- 24 h
- Temp.:
- 20 °C
- pH:
- 4
- Remarks on result:
- completely miscible
- Conclusions:
- Water solutbility 3300mg/l at 20C
Reference
Description of key information
Key value for chemical safety assessment
- Water solubility:
- 3 300 mg/L
- at the temperature of:
- 20 °C
Additional information
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