Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-03-20 to 2017-05-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.1 (Melting / Freezing Temperature)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7200 (Melting Point / Melting Range)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
differential scanning calorimetry

Test material

Constituent 1
Chemical structure
Reference substance name:
(4-amino-1-hydroxy-1-phosphonobutyl)phosphonic acid hydrate
EC Number:
680-378-7
Cas Number:
138624-11-0
Molecular formula:
C4H15NO8P2
IUPAC Name:
(4-amino-1-hydroxy-1-phosphonobutyl)phosphonic acid hydrate
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor and 610-GTH
- Purity test date: 2016-04-16

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light

Results and discussion

Melting / freezing point
Key result
Melting / freezing pt.:
>= 236.7 - <= 243.4 °C
Atm. press.:
ca. 1 atm
Decomposition:
yes
Decomp. temp.:
>= 236.7 - <= 243.4 °C

Applicant's summary and conclusion

Conclusions:
The melting point range of Alendronic acid monohydrate was determined to be 236.7-234.4 degrees Celsius according to the given guidelines.