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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:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
other: draft guidance document EUR 20268 (20029, part 5.2 “Laser scattering /diffraction” for “Particle Size Distribution, Fibre Length and Diameter Distribution”, European Commission, Directorate General JRC)
Principles of method if other than guideline:
This test method defines the size of particles dispersed as a dry powder by applying laser diffraction technology
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Key result
Percentile:
D10
Mean:
0.75 µm
Remarks on result:
other: average of 2 tests
Key result
Percentile:
D50
Mean:
4.08 µm
Remarks on result:
other: average of 2 tests
Key result
Percentile:
D90
Mean:
224.5 µm
Remarks on result:
other: average of 2 tests
No.:
#1
Size:
< 4 µm
Distribution:
ca. 49 %
No.:
#2
Size:
< 10 µm
Distribution:
ca. 75 %
No.:
#3
Size:
< 100 µm
Distribution:
ca. 85 %

The evaluation corresponds to the average value of two measurements of the same lot.

The particle size range from 0.33µm to 600µm

The particle size distribution of test substance was determined n the size range from 0.33 µm to 600 µm.

Conclusions:
The particle size distribution of test substance was determined to be MMD= 4 µm

Description of key information

MMD= 4.0 µm

D10= 0.7 µm

D90= 224 µm

in the size range from 0.33 to 600 µm

Additional information

The determination was carried out by laser diffraction method. The measurement of the dry powder was chosen as the key study


In addition, the values [vol%] for the particle size fractions are as follows:


<4 µm= 49%


<10 µm= 75%


<100 µm= 85%