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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 May 2019 - 16 May 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
other: Density study used for MMAD calculation
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
Specific details on test material used for the study:
Relative density: 1.26
Mass median aerodynamic diameter:
83.9 µm
Geometric standard deviation:
2.221
Remarks on result:
other: MMAD and GSD above are both the average of 5 runs. The St.dev. in the table below is the population standard deviation [µm].
Key result
Percentile:
D10
Mean:
< 20.3 µm
St. dev.:
0.355
Key result
Percentile:
D50
Mean:
< 74.7 µm
St. dev.:
0.854
Key result
Percentile:
D90
Mean:
< 143 µm
St. dev.:
2.21

The coefficient of variation for d50 is less than 3%, d10 and d90 are less than 5%.


The Volume of sample <9.86 μm was 0.75%.


The Volume weighted mean was 79.5 μm


The Mode was 89.1 μm

Conclusions:
The D50 of the test item was determined to be 74.7 μm, the D10 was 20.3 μm and the D90 was 143 μm. The volume of sample <9.86 μm was 0.75%. The MMAD of the test item was calculated to be 83.9 μm.
Executive summary:

Laser diffraction analysis (medium volume wet module) was performed in a GLP study according to ISO 13320 and CIPAC MT 187. Each result is the average of five runs. The D50 of the test item was determined to be 74.7 μm, the D10 was 20.3 μm and the D90 was 143 μm. The volume of sample <9.86 μm was 0.75%. The MMAD of the test item was calculated to be 83.9 μm.

Description of key information

D10= 20.3 µm; D50= 74.7 µm; D90=143 µm. 0.75% is smaller than <9.86 μm. MMAD= 83.9 µm (ISO 13320: laser diffraction analysis).

Additional information