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EC number: 866-700-0 | CAS number: 2102522-55-2
Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 July 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187
- Version / remarks:
- 2007
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- agglomerate
- Type of distribution:
- volumetric distribution
- Mass median aerodynamic diameter:
- 21.8 µm
- Geometric standard deviation:
- 2.532
- Key result
- Percentile:
- D10
- Mean:
- 7.12 µm
- St. dev.:
- 0.082
- Key result
- Percentile:
- D50
- Mean:
- 21.8 µm
- St. dev.:
- 0.297
- Key result
- Percentile:
- D90
- Mean:
- 81.5 µm
- St. dev.:
- 1.41
- Conclusions:
- Under the conditions of the study the d10, d50 and d90 of the test material were 7.12, 21.8 and 81.5 µm, respectively.
- Executive summary:
The particle size distribution of the test material was investigated in accordance with the standardised guideline ISO 13320-1, under GLP conditions.
The particle size was investigated using microscope analysis and laser diffraction. The coefficient of variation for d50 was less than 3 %; d10 and d90 were less than 5 %. Thus repeatability of the characteristic particles in the size distribution is within the acceptable limits.
Under the conditions of the study the d10, d50 and d90 of the test material were 7.12, 21.8 and 81.5 µm, respectively.
Reference
Optical Microscope Analysis
Direct observation: Test material observed to be a fine and medium, off-white powder with clusters.
Under a microscope with 100 x magnification: The particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately 3 μm and the largest individual size was approximately 160 μm.
Under a microscope with 400 x magnification: The test material was observed to be made up of single crystalline particles.
Laser Diffraction Particle Size Analysis
Full Test Results
|
Run 1 |
Run 2 |
Run 3 |
Run 4 |
Run 5 |
Average |
STDVP |
% STDVP |
VWM |
34.7 |
34.3 |
33.9 |
34.2 |
35.2 |
34.5 |
N/A |
N/A |
Mode |
18.6 |
18.6 |
18.4 |
18.3 |
18.9 |
18.6 |
N/A |
N/A |
d10 |
7.21 |
7.18 |
7.05 |
7.02 |
7.16 |
7.12 |
0.0817 |
1.15 |
d50 (Median) |
22.1 |
21.9 |
21.5 |
21.6 |
22.2 |
21.8 |
0.297 |
1.36 |
d90 |
82.0 |
80.6 |
80.0 |
81.3 |
83.6 |
81.5 |
1.41 |
1.73 |
GSD |
2.531 |
2.519 |
2.523 |
2.537 |
2.550 |
2.532 |
0.011 |
0.4 |
All particle size results are in μm
18.72 % by volume of sample was seen to be < 10.00 μm
Definitions
VWM : volume weighted mean
d10 : 10 % of the test item is less than this particle size
d50 : 50 % of the test item is less than this particle size
d90 : 90 % of the test item is less than this particle size
GSD : geometric standard deviation of the lognormal particle size
distribution
Average : calculated from the entirety of the data captured in each run
and not
a simple arithmetic mean
STDVP : standard deviation of the population
% STDVP : percentage standard deviation of the population
The coefficient of variation for d50 was less than 3 %; d10 and d90 were less than 5 %. Thus repeatability of the characteristic particles in the size distribution is within the acceptable limits as per the ISO 13320-1 test standard.
Description of key information
The d10, d50 and d90 of the test material were 7.12, 21.8 and 81.5 µm, respectively.
Additional information
The particle size distribution of the test material was investigated in accordance with the standardised guideline ISO 13320-1, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).
The particle size was investigated using microscope analysis and laser diffraction.The coefficient of variation for d50 was less than 3 %; d10 and d90 were less than 5 %. Thus repeatability of the characteristic particles in the size distribution is within the acceptable limits.
Under the conditions of the study the d10, d50 and d90 of the test material were 7.12, 21.8 and 81.5 µm, respectively.
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