Registration Dossier

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: Modern GLP study peformed on the basis of EC directive 92/69/EEC A.1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes
Type of method:
capillary method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
The test material received from F. Hoffmann-La Roche Ltd was a white solid powder from lot no. 25927 with a purity of 99.8%.

Results and discussion

Melting / freezing point
Melting / freezing pt.:
115.5 - 116.6 °C

Any other information on results incl. tables

The following melting temperature ranges for PTH-Decahydroamide were measured;

115.6 -116.6 ⁰C

115.4 -116.5 ⁰C

115.6 -116.7 ⁰C

The average melting point of PTH-decahydroamide (Ro 31 -9373/000) was determined to be 115.5 -116.6 ⁰C.

No decomposition of the test substance was noticed before the melting temperature is reached.

Applicant's summary and conclusion

Conclusions:
The melting point of PTH-decahydroamide (Ro 31 -9373/000) was determined to be 115.5 -116.6 ⁰C.
Executive summary:

The melting point of PTH-decahydroamide was obtained using the EU method A.1. The melting point of PTH-decahydroamide (Ro 31 -9373/000) was determined to be 115.5 -116.6 ⁰C.