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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Principles of method if other than guideline:
The sample was observed under 3 conditions: Direct observation, under a microscope with 100 x magnification, under a microscope with 400 x magnification. The physical characteristics of the material were recorded, noting such items as shape and size distribution.
GLP compliance:
yes (incl. certificate)
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:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor and G316533
- Expiration date of the lot/batch: 25 March 2018
- Purity test date: 22 August 2017
Remarks on result:
other: 12.52 % by volume of sample was seen to be < 10.00 µm.
Key result
Percentile:
D10
Mean:
53.005 µm
St. dev.:
0.195
Remarks on result:
other: % STDVP 0.4
Key result
Percentile:
D50
Mean:
130.126 µm
St. dev.:
0.166
Remarks on result:
other: % STDVP 0.1
Key result
Percentile:
D90
Mean:
227.605 µm
St. dev.:
0.45
Remarks on result:
other: %STDVP 0.2

Standard visual observation

Sample observed to be a fine and medium size, light brown powder with clusters.

Observation at 100 x magnification

The particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately < 10 µm and the largest individual size was approximately 259 µm.

Observation at 400 x magnification

The sample was observed to be made up of single crystalline particles.

Conclusions:
The particle sizes were distributed (D10-D90) between 53 and 227.6µm with the median particle size (50th %tile) 130.126 µm. 12.5% of the particles were <10µm and 31% of particles were <100µm.

Description of key information

The particle sizes were distributed (D10-D90) between 53 and 227.6µm with the median particle size (50th %tile)  130.126 µm. 12.5% of the particles were <10µm and 31% of particles were <100µm.

Additional information