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:
key study
Study period:
2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Solubility and stability of the test item was tested in NMP, DMSO, DMF, 1,4-dioxane, acetonitrile, ethanol, methanol, acetone (see section “Any other information on results incl. tables”)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- lot/batch No.of test material: 01256BJ7

Results and discussion

Test substance stable:
no
Remarks:
in NMP and DMF, but stable in DMSO

Any other information on results incl. tables

Solubility and stability of test item:

test solvent solubility measured by
UV/VIS
N-pyrrolidone (NMP) low solubility not stable
dimethylsulfoxide (DMSO) low solubility stable
dimethylformamide (DMF) low solubility not stable
1,4-dioxane not soluble not stable
acetonitrile  not soluble not stable
ethanol  not soluble not stable
methanol  not soluble not stable
acetone not soluble -

Applicant's summary and conclusion