Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
other information
Study period:
2001-12-06 to 2001-12-17
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Water solubility:
0.149 g/L
Temp.:
20 °C
pH:
6.2

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): moderately soluble (100-1000 mg/L)
Executive summary:

The water solubility of ZK 34517 was determined using the flask method. The following solubility of the substance in saturated solution was obtained after equilibration at 20 °C and separation from the insoluble residues :

S20°C = 0.149 g/L ± 0.003 g/L.

The pH value of the aqueous solution was determined to be 6.2. ZK 34517 can be considered as very slightly soluble in accordance with the descriptive term of Ph.Eur., 3rd Edition and USP 24. According to X-ray powder diffraction the starting material (batch 28072009) consists of the same solid state form as the insoluble residue.