Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Melting point / freezing point
Administrative data
- Endpoint:
- melting point/freezing point
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Jan 2021 to 17 Mar 2021
- 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:
- 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 102 (Melting point / Melting Range)
- Version / remarks:
- 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7200 (Melting Point / Melting Range)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- differential scanning calorimetry
Test material
- Reference substance name:
- N-[4-[4-[(dimethylamino)methyl]-3-phenyl-1H-pyrazol-1-yl]pyrimidin-2-yl]-6-methoxy-4-(morpholin-4-yl)benzene-1,3-diamine
- Cas Number:
- 1903009-56-2
- Molecular formula:
- C27H32N8O2
- IUPAC Name:
- N-[4-[4-[(dimethylamino)methyl]-3-phenyl-1H-pyrazol-1-yl]pyrimidin-2-yl]-6-methoxy-4-(morpholin-4-yl)benzene-1,3-diamine
- Test material form:
- solid: particulate/powder
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch (Lot) Number: I20ID2980
- Purity/Composition: 95.0%
- Purity/Composition correction factor: 1.0
- Purity test date : 2020-10-26
- Expiry date: 17 September 2022 (retest date)
- Physical Description: Beige powder
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
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.:
- 183.7 °C
- Atm. press.:
- 1 013.25 hPa
- Decomposition:
- yes
- Decomp. temp.:
- 300 °C
Any other information on results incl. tables
Preliminary Test
Starting at 350°C, the weight of the sample decreased significantly. At 380°C, the sample weight had decreased by 25%.
After the experiment, a black molten residue remained in the sample container (original colour: Beige). The change of the colour indicated reaction and/or decomposition of the test item.
Main Study
An endothermic effect was observed between 175°C and 200°C followed by an exothermic effect starting at 300°C. The extrapolated onset temperature of the first effect was 183.686°C. The endothermic effect was most likely obtained due to melting of the test item. The exothermic effect was probably obtained due to reaction and/or decomposition of the test item. After the experiment, a black molten residue remained in the sample container (original colour: Beige). 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 183.614°C. After the experiment, an orange brown molten residue remained in the sample container (original colour: beige). 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.
The melting temperature was determined as the mean melting temperature of Experiment 1 (183.686°C) and Experiment 2 (183.614°C).
Applicant's summary and conclusion
- Conclusions:
- The melting temperature of JNJ-73848281-AAA (T003904) were determined by DSC.
The melting temperature of the test item was 183.7°C (456.8K).
Reaction and/or decomposition of the test item was observed during DSC experiment starting during melting.
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