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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:
- 23 SEP 2022 TO 23 SEP 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2020
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187: Particle Size Analysis by Laser Diffraction, Handbook K.
- Version / remarks:
- 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
- Reference substance name:
- 4-[(1-[[6-cyano-5-(trifluoromethyl)pyridin-3-yl]carbamoyl]cyclobutyl)amino]-2-fluoro-N-methylbenzamide
- Cas Number:
- 1950587-20-8
- Molecular formula:
- C20H17F4N5O2
- IUPAC Name:
- 4-[(1-[[6-cyano-5-(trifluoromethyl)pyridin-3-yl]carbamoyl]cyclobutyl)amino]-2-fluoro-N-methylbenzamide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch number of test material: 22CN0611
- Expiry date: 11 May 2023 (retest date)
- Purity test date: 31 May 2022 (certificate of analysis release date)
- Physical Description: Brown powder
- Purity: 99.9%
- Purity correction factor: no correction factor required
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
Results and discussion
- Mass median aerodynamic diameter:
- 77.7
- Geometric standard deviation:
- 2.702
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- 19.5 µm
- St. dev.:
- 0.124
- Key result
- Percentile:
- D50
- Mean:
- 64.5 µm
- St. dev.:
- 0.124
- Key result
- Percentile:
- D90
- Mean:
- 215 µm
- St. dev.:
- 9.07
Any other information on results incl. tables
The particle size distribution of the test material was analysed over the range 0.01 µm to 3500 µm.
The coefficient of variation for D50 is less than 2.5%, for D10 less than 3% and for D90 4%. 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 material was determined by means of Laser Diffraction Analysis using the Aero S dry powder module.
The D50 of the test material was determined to be 64.5 µm, the D10 was 19.5 µm and the D90 was 215 µm. The MMAD of the test material, for the relative density and the mean D50, was calculated to be 77.7 µm.
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