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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:
2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method Principle of light scattering by the particles.

It uses the "Mie theory" to predict how light is scattered by the particles. Each particle size will have its own characteristic diffraction image. The diffraction pattern produced by the particles is measured, and the particle size is calculated from the result of this measurement. The typical size range of particles measured by this method is between 0.1µm and 10µm.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
other: Milled primary particle.
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
PHI/070717/Lot 2 Bag 115.
Percentile:
other: D100
Mean:
ca. 31.39 µm
Remarks on result:
other: No source field for Standard deviation.
Percentile:
D95
Mean:
ca. 13.82 µm
Remarks on result:
other: No source field for Standard deviation.
Percentile:
D90
Mean:
ca. 10.85 µm
Remarks on result:
other: No source field for Standard deviation.
Percentile:
D75
Mean:
ca. 6.858 µm
Remarks on result:
other: No source field for Standard deviation.
Percentile:
D50
Mean:
ca. 3.718 µm
Remarks on result:
other: No source field for Standard deviation.
Percentile:
D25
Mean:
ca. 1.743 µm
Remarks on result:
other: No source field for Standard deviation.
Percentile:
D10
Mean:
ca. 0.749 µm
Remarks on result:
other: No source field for Standard deviation.
No.:
#1
Size:
> 0 - < 0.1 µm
Distribution:
ca. 0.62 %
No.:
#2
Size:
> 0.2 - < 0.5 µm
Distribution:
ca. 1.9 %
No.:
#3
Size:
> 0.5 - < 1 µm
Distribution:
ca. 6.21 %
No.:
#4
Size:
> 1 - < 2 µm
Distribution:
ca. 13.84 %
No.:
#5
Size:
> 2 - < 5 µm
Distribution:
ca. 28.68 %
No.:
#6
Size:
> 5 - < 10 µm
Distribution:
ca. 62.1 %
No.:
#7
Size:
> 10 - < 20 µm
Distribution:
ca. 87.85 %
No.:
#8
Size:
> 20 - < 45 µm
Distribution:
ca. 98.89 %
No.:
#9
Size:
> 45 - < 75 µm
Distribution:
ca. 100 %
No.:
#10
Size:
> 75 µm
Distribution:
ca. 100 %

Particle was spherical in shape.

Conclusions:
The test showed the median particle size was 3.718 µm.
Executive summary:

A light scattering method according to ISO 21501-2:2007 was performed to measure the particle size distribution (granulometry) of the susbtance. The median particle size (D50) was 3.718 µm with a spherical shape.

Description of key information

A light scattering method according to ISO 21501 -2:2007 was performed to measure the particle size distribution (granulometry) of the susbtance. The median particle size (D50) was 3.718 µm with a spherical shape.

Additional information