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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:
- 04 Mar 2021 to 04 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: 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-[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
- Purity/Composition: 97.1%
- Purity test date : 01 September 2020
- Expiry date: 15 August 2022 (retest date)
- Physical Description: Yellow powder
- Purity/Composition correction factor: 1.00
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
Results and discussion
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- 2.3 µm
- St. dev.:
- 0.015
- Key result
- Percentile:
- D50
- Mean:
- 7.25 µm
- St. dev.:
- 0.028
- Key result
- Percentile:
- D90
- Mean:
- 17 µm
- St. dev.:
- 0.062
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.
67.11 % by volume of sample was seen to be < 10.00 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 particle size distribution of the test item was determined by means of Laser Diffraction Analysis using the Aero S dry powder module.
The D50 of the test item was determined to be 7.25 µm, the D10 was 2.30 µm and the D90 was 17.0 µm. The MMAD of the test item, for the relative density and the mean d50, was calculated to be 8.33 µm.
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