Registration Dossier
Registration Dossier
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EC number: 211-560-2 | CAS number: 665-66-7
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Principles of method if other than guideline:
- External method EM/00408/01 from Competence Center Analytics, BASF SE {chapter 4: visual method) was applied to investigate
complete miscibility - GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Reference substance name:
- Amantadine hydrochloride
- EC Number:
- 211-560-2
- EC Name:
- Amantadine hydrochloride
- Cas Number:
- 665-66-7
- Molecular formula:
- C10H17N.ClH
- IUPAC Name:
- adamantan-1-amine hydrochloride
- Test material form:
- other: solid
- Details on test material:
- Name of test material (as cited in study report): 1-Aminoadamantanhydrochlrid
Analytical purity: 99.7 g/100g by 1H-NMR spectroscopy using the internal standard method (determined during the GLP-study No.
11 L00389 from Competence Center Analytics, BASF SE)
Lot/batch No.: 20110315
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- > 35 - < 39.8 other: g/100g
- Temp.:
- 20
- pH:
- 4.2 - 4.4
Any other information on results incl. tables
The solubility (miscibility) of the test item in water at room temperature (23°C) and at 20.0°C ± 0.5°C is >= 35.0 gl100g <39.8 g/100g.
Applicant's summary and conclusion
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