Registration Dossier
Registration Dossier
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EC number: 680-378-7 | CAS number: 138624-11-0
Melting point / freezing point
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:
- 2 017
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
- 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
Constituent 1
- 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.
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