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Diss Factsheets

Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 Okt 2020 to 29 Okt 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2021

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187: Particle Size Analysis by Laser Diffraction, Handbook K. 2007
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
N-{5-[(4-{4-[(dimethylamino)methyl]-3-phenyl-1H-pyrazol-1-yl}pyrimidin-2-yl)amino]-4-methoxy-2-(morpholin-4-yl)phenyl}prop-2-enamide
EC Number:
841-500-6
Cas Number:
1903008-80-9
Molecular formula:
C30H34N8O3
IUPAC Name:
N-{5-[(4-{4-[(dimethylamino)methyl]-3-phenyl-1H-pyrazol-1-yl}pyrimidin-2-yl)amino]-4-methoxy-2-(morpholin-4-yl)phenyl}prop-2-enamide
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- lot/batch number of test material: M20BD0542
- Expiry date: 19 February 2022 (retest date)
- Physical Description: Slightly greenish yellow powder
- Purity: 99.8%
- Purity correction factor: 1.00

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature

Results and discussion

Mass median aerodynamic diameter:
46.5
Geometric standard deviation:
3.227
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
7.28
St. dev.:
0.098
Remarks on result:
other: standard deviation of the population
Key result
Percentile:
D50
Mean:
40.9
St. dev.:
0.919
Remarks on result:
other: standard deviation of the population
Key result
Percentile:
D90
Mean:
136
St. dev.:
3.91
Remarks on result:
other: standard deviation of the population

Any other information on results incl. tables

In the preliminary test, the substance was concluded to be visually insoluble in the dispersant, thus only dispersability was investigated in the main test.


The test item proved to be homogeneously and well dispersed in Milli-Ro water and therefore this solvent was used as the dispersant in the Laser Diffraction Analysis.


The particle size distribution of the test item was analysed over the range 0.01 μm to 1400 μm.


The coefficient of variation for D50 is less than 3%, and for D10 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 particle size distribution of the test item was determined by means of Laser Diffraction
Analysis using the medium volume (wet) module (MVM).
The D50 of the test item was determined to be 40.9 μm, the D10 was 7.28 μm and the D90 was 136 μm. The MMAD of the test item, for the relative density and the mean d50, was calculated to be 46.5 μm.