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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:
- 21 August 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187 - Particle size analysis by laser diffraction
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of GLP Inspection: 25 January 2018 - 26 January 2018 Date of Issue: 10 September 2018
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- agglomerate
- Type of distribution:
- volumetric distribution
- Mass median aerodynamic diameter:
- 12.4 µm
- Geometric standard deviation:
- 2.086
- Key result
- Percentile:
- D50
- Mean:
- 6.15 µm
- St. dev.:
- 0.072
- Percentile:
- D10
- Mean:
- 3.07 µm
- St. dev.:
- 0.057
- Percentile:
- D90
- Mean:
- 11.9 µm
- St. dev.:
- 0.06
- Conclusions:
- The d10 was determined to be 3.07 µm, d50 was determined to be 6.15 µm, d90 was determined to be 11.9 µm. 82.84% of the sample is less than 10.0 µm. The results do not show any particles < 100 nm (0.1 µm).
- Executive summary:
The results of the laser diffraction test conducted to determine the particle size of the test substance are summarised in the table below. The analysis was conducted using the small volume (wet) module (SVM) with water as the dispersant.
Particle size analysis using small volume (wet) module (SVM)
Average (µm)
Volume weighted mean
9.99
Mode
6.25
d10 (10% of material is <)
3.07
d50 (50% of material is <) median
6.15
d90 (90% of material is <)
1.19
MMAD (mass median aerodynamic diameter)
12.4
Volume of sample < 10.00 µm
82.84 %
The results do not show any particles < 100 nm (0.1 µm).
Reference
During the method development phase of the analysis trials were conducted using the small volume (wet) module (SVM) only. The SVM trials were conducted using water as the dispersant. The results of these trials indicated that the most appropriate test and material parameters to obtain the optimum measurements were:
Module: SVM
Dispersant: Water
Dispersion speed: 1700 rpm
Refractive index (sample): 0.000 n
Absorption: 0.000 AU
Analysis model: General purpose (normal)
Using the identified parameters, the particle size was analysed over the range 0.01 µm to 3500 µm. The results of the formal analysis are presented in Table 1. In addition, a graph of volume (%) versus Particle Diameter (µm) and full particle size distribution, is attached.
Table 1: Full Test Results
|
Run 1 |
Run 2 |
Run 3 |
Run 4 |
Run 5 |
Average |
STDVP |
% STD VP |
VWM |
8.26 |
9.28 |
10.1 |
10.9 |
11.4 |
9.99 |
N/A |
N/A |
Mode |
6.38 |
6.30 |
6.24 |
6.19 |
6.15 |
6.25 |
N/A |
N/A |
d10 |
3.15 |
3.10 |
3.07 |
3.03 |
3.00 |
3.07 |
0.0572 |
1.86 |
d50 (median) |
6.24 |
6.19 |
6.14 |
6.10 |
6.06 |
6.15 |
0.0717 |
1.17 |
d90 |
11.9 |
11.9 |
12.0 |
12.0 |
12.0 |
11.9 |
0.0602 |
0.504 |
MMAD |
12.6 |
12.5 |
12.4 |
12.4 |
12.3 |
12.4 |
0.130 |
1.0 |
GSD |
1.884 |
2.010 |
2.107 |
2.185 |
2.236 |
2.086 |
0.126 |
6.0 |
All particle size results are in µm
82.84% 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 distribition
MMAD: mass median aerodynamic diameter
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 is less than 3 %; d10 and d90 are 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
82.84% particles < 10 µm in diameter, d50: 6.15 µm; CIPAC MT 87; Livingston, I (2018)
Additional information
The results do not show any particles < 100 nm (0.1 µm).
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