Registration Dossier
Registration Dossier
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EC number: 627-199-2 | CAS number: 120728-10-1
Melting point / freezing point
Administrative data
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Aug 2020 to 25 Sep 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.1 (Melting / Freezing Temperature)
- Version / remarks:
- March 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 102 (Melting point / Melting Range)
- Version / remarks:
- July 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7200 (Melting Point / Melting Range)
- Version / remarks:
- March 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- differential scanning calorimetry
Test material
- Reference substance name:
- 1-[(tert-butoxycarbonyl)amino]cyclobutane-1-carboxylic acid
- EC Number:
- 627-199-2
- Cas Number:
- 120728-10-1
- Molecular formula:
- C10H17NO4
- IUPAC Name:
- 1-[(tert-butoxycarbonyl)amino]cyclobutane-1-carboxylic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- Physical state: powder
Appearance: white powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch number of test material: AC07N1912008
- Expiry date: 02 January 2021 (retest date)
- Physical Description: Almost white powder
- Purity: 98.9%
- Purity test date: 15 June 2020
- Purity correction factor: no correction factor required
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under storage conditions: not indicated
- Stability under test conditions: not applicable
- Solubility and stability of the test item in the solvent/vehicle: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: not applicable, the solid test item was transferred directly into the DSC cell
Results and discussion
Melting / freezing point
- Key result
- Melting / freezing pt.:
- 133.375 °C
- Atm. press.:
- 1 atm
- Decomposition:
- yes
- Decomp. temp.:
- 170 °C
- Remarks on result:
- other: mean melting temperature of Experiment 1 (133.317°C) and Experiment 2 (133.432°C).
Any other information on results incl. tables
Preliminary test
From the TGA curve it could be derived that starting at 175°C, the weight of the sample decreased significantly. At 194°C, the sample weight had decreased by 25%. After the experiment, a brown molten residue remained in the sample container (original colour: white). The change of the colour indicated reaction and/or decomposition of the test item.
Main study
From the DSC curve obtained with experiment 1, an endothermic effect was observed between 120°C and 140°C followed by an endothermic and exothermic effect starting at 170°C. The extrapolated onset temperature of the first effect was 133.317°C. The endothermic effect was most likely obtained due to melting of the test item. The endothermic and exothermic effect were probably obtained due to reaction and/or decomposition of the test item.
After the experiment, a yellow molten residue remained in the sample container (original colour: white). The change of the colour indicated reaction and/or decomposition of the test item. Based on this visual observation, it was found that the test item had molten and the change of the colour demonstrated reaction and/or decomposition of the test item.
In order to investigate the endothermic effect, Experiment 2 was stopped directly after the melting effect. The extrapolated onset temperature was 133.432°C. After the experiment, a colourless molten residue remained in the sample container (original colour: white) It demonstrated that melting was the reason for the endothermic effect.
The melting temperature was determined as the mean melting temperature of Experiment 1 (133.317°C) and Experiment 2 (133.432°C).
Applicant's summary and conclusion
- Conclusions:
- The melting temperature of JNJ-63543883-AAA (T003661) was determined by DSC.
The melting temperature of the test item was 133.375°C (406.5K).
Reaction and/or decomposition of the test item was observed during DSC experiment starting at 170°C (443K).
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