Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 Mar 2021 to 03 Mar 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187
- Version / remarks:
- 2007
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
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: 99.3%
- 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
Results and discussion
- Mass median aerodynamic diameter:
- 8.41 µm
- Geometric standard deviation:
- 3.276
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- 1.55 µm
- St. dev.:
- 0.032
- Remarks on result:
- other: standard deviation of the population
- Key result
- Percentile:
- D50
- Mean:
- 7.46 µm
- St. dev.:
- 0.146
- Remarks on result:
- other: standard deviation of the population
- Key result
- Percentile:
- D90
- Mean:
- 29.2 µm
- St. dev.:
- 0.477
- Remarks on result:
- other: standard deviation of the population
Any other information on results incl. tables
The particle size distribution of the test item was analysed over the range 0.01 μm to 3500 μm.
The coefficient of variation for d50 is less than 6%, for d10 is less than 10% and d90 is less than 5%. It can be concluded that the repeatability of the measured particle size distributions is within the acceptable limits.
Applicant's summary and conclusion
- Conclusions:
- The D50 of the test item was determined to be 7.46 μm, the D10 was 1.55 μm and the D90 was 29.2 μm. The MMAD of the test item, for the relative density and the mean d50, was calculated to be 8.41 μm.
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