Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study and GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
GLP compliance:
yes (incl. QA statement)
Type of method:
other: DSC

Test material

Results and discussion

Melting / freezing point
Atm. press.:
1 013 mBar
Remarks on result:
other: The test item shows no melting of crystalline subcomponents between -90 °C and 50 °C.

Applicant's summary and conclusion

Conclusions:
The test item shows no melting of crystalline subcomponents between -90 °C and 50 °C.