Registration Dossier

Physical & Chemical properties

Stability in organic solvents and identity of relevant degradation products

Administrative data

Endpoint:
stability in organic solvents and identity of relevant degradation products
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
according to company guideline, but limited documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Principles of method if other than guideline:
UV-Vis analysis of test substance solutions in DMSO and in 1,2-propylene glycol after stirring for 72 hours at room temperature

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: nanoform

Results and discussion

Test substance stable:
yes

Any other information on results incl. tables

The test substance is more than 72 hours stable and homogeneous in DMSO and 1,2 -propylene glycol (0.1 and 50 mg/mL) at room temperature.

Method: UV-vis-spectrometry

Applicant's summary and conclusion

Conclusions:
The test substance is more than 72 hours stable and homogeneous in DMSO and 1,2-propylene glycol at room temperature.