Registration Dossier

Diss Factsheets

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:
2013
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

Constituent 1
Chemical structure
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

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