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 18 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:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- differential scanning calorimetry
Test material
- Reference substance name:
- 4-[4-[(dimethylamino)methyl]-3-phenyl-1H-pyrazol-1-yl]-N-[2-methoxy-4-(morpholin-4-yl)-5-nitrophenyl]pyrimidin-2-amine
- Cas Number:
- 1903009-55-1
- Molecular formula:
- C27H30N8O4
- IUPAC Name:
- 4-[4-[(dimethylamino)methyl]-3-phenyl-1H-pyrazol-1-yl]-N-[2-methoxy-4-(morpholin-4-yl)-5-nitrophenyl]pyrimidin-2-amine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
Batch (Lot) Number: I20HD2581
Expiry date: 15 August 2022
Physical Description: Yellow powder
Purity: 97.1%
Purity/Composition correction factor: 1.00
STORAGE CONDITIONS
Storage Conditions: At room temperature
Results and discussion
Melting / freezing point
- Key result
- Melting / freezing pt.:
- 216.6 °C
- Atm. press.:
- 1 013.25 hPa
- Decomposition:
- yes
- Decomp. temp.:
- 225 °C
Any other information on results incl. tables
Preliminary Test
Starting at 250°C, the weight of the sample decreased significantly. At 375°C, the sample weight had decreased by 25%.
After the experiment, a black molten residue remained in the sample container (original colour: Yellow). The change of the colour indicated reaction and/or decomposition of the test item.
Main Study
An endothermic effect was observed between 200°C and 225°C directly followed by a strong exothermic effect. The extrapolated onset temperature of the first effect was 216.518°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: Yellow). 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 216.745°C. After the experiment, a red brown molten residue remained in the sample container (original colour: yellow). 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 (216.518°C) and Experiment 2 (216.745°C).
Applicant's summary and conclusion
- Conclusions:
- The melting and boiling temperature of JNJ-73848268-AAA (T003903) were determined by DSC.
The melting temperature of the test item was 216.6°C (489.8K).
Reaction and/or decomposition of the test item was observed during DSC experiments during melting.
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