Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-04-09
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Principles of method if other than guideline:
Testing method as described in the European Pharmacopoeia 7.0
GLP compliance:
not specified
Type of method:
other: European Pharmacopoeia

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch no. 2014040029
Expiry date April 2015 (provisional)

Results and discussion

Water solubility
Water solubility:
> 1 - < 10 mg/L
Temp.:
20 °C
Remarks on result:
other: measured on aqueous solution

Any other information on results incl. tables

The test result was determined accordingly European Pharmacopoeia general notices.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: Freely soluble.From 1 to 10 parts
The substance (aqueous solution) is freely soluble in water.