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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
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other: draft guidance document EUR 20268 (20029, part 5.2 “Laser scattering /diffraction” for “Particle Size Distribution, Fibre Length and Diameter Distribution”, European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
Specific details on test material used for the study:
- Lot/batch No.: 020203K0
- Expiration date of the lot/batch: January 01, 2007
Key result
Percentile:
D10
Mean:
2.17 µm
Remarks on result:
other: Average of 2 measurements
Key result
Percentile:
D50
Mean:
10.44 µm
Remarks on result:
other: Average of 2 measurements
Key result
Percentile:
D90
Mean:
120.33 µm
Remarks on result:
other: Average of 2 measurements
No.:
#1
Size:
< 4 µm
Distribution:
ca. 22.5 %
No.:
#2
Size:
< 10 µm
Distribution:
ca. 47 %
No.:
#3
Size:
< 100 µm
Distribution:
ca. 84.5 %

Particle size in the range from 0.3 to 467µm

Conclusions:
The particle size distribution of test substance was determined to be MMD= 10.4 µm

Description of key information

MMD= 10 µm

D10= 2 µm

D90= 120 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= 23%


<10 µm= 47%


<100 µm= 85%