Registration Dossier

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Test material form:
solid: bulk
Details on test material:
This composition is the usual techical grade of AlzChem AG. It will be used when test substance has this composition (or is very closed) or no specific information is available

Results and discussion

Water solubility
Key result
Water solubility:
ca. 0.87 g/L
Conc. based on:
test mat.
Temp.:
22 °C
pH:
> 3 - <= 3.6

Any other information on results incl. tables

Sample

Result (g/l at 22 °C)

Method

1stsaturated solution

0.87

HPLC

2ndsaturated solution

0.87

HPLC

3rdsaturated solution

0.88

HPLC

Average

0.87

(-)

Applicant's summary and conclusion

Conclusions:
The average water solubility of alpha-Lipoic acid is 0.87 g/L at 22 °C.
Executive summary:

The average water solubility of alpha-Lipoic acid is 0.87 g/L at 22 °C.