Registration Dossier
Registration Dossier
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EC number: 700-317-0 | CAS number: -
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 07, 2007-September 14, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to EC and/or OECD guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- flask method
Test material
- Reference substance name:
- tert-butyl N-[(1S,3S,4S)-4-hydroxy-4-[4-methoxy-3-(3-methoxypropoxy)phenyl]-1-[(2S,4S)-5-oxo-4-(propan-2-yl)oxolan-2-yl]-3-(propan-2-yl)butyl]carbamate
- EC Number:
- 700-317-0
- Cas Number:
- 934841-33-5
- Molecular formula:
- C30H49NO8
- IUPAC Name:
- tert-butyl N-[(1S,3S,4S)-4-hydroxy-4-[4-methoxy-3-(3-methoxypropoxy)phenyl]-1-[(2S,4S)-5-oxo-4-(propan-2-yl)oxolan-2-yl]-3-(propan-2-yl)butyl]carbamate
- Details on test material:
- - Name of test material (as cited in study report): SPP100 C6
- Molecular formula: C30H49NO8
- Molecular weight: 551.73
- Analytical purity: 99.2% (HPLC, sum of isomers 1 and 2)
- Impurities (identity and concentrations):
significant impurities: sum of all impurities by HPLC: 0.8%
- solvent content:
Isopropyl acetate: 1.9% (w/w)
Methylcyclohexane: 5.8% (w/w)
- Lot/batch No.: HH-853.35Kr
- Stability/Expiration date of the lot/batch: December 2007
findings of test facility:
Content of water: 0.20% w/w (volumetric Karl Fischer titration)
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- 102.2 mg/L
- Temp.:
- 20 °C
- pH:
- > 5.2 - < 6
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): moderately soluble (100-1000 mg/L)
The water solubility of SPP100 C6 was determined to be 102.2 mg/l at 20°C using the flask method.
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