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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:
16 January 2018
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 analysis was conducted initially using a visual microscope and was then undertaken more formally using a Laser Diffraction Particle Size Analyser. The sample was observed under 3 conditions: Direct observation, under a microscope with 32 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. Following this the Malvern Mastersizer 2000 Laser Diffraction Analyser was used. Five runs of the method were conducted to ensure repeatability of results.
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 and lot/batch No.of test material: Sponsor and G316507
Mass median aerodynamic diameter:
6.209 µm
Geometric standard deviation:
0.364
Remarks on result:
other: 63.80 % by volume of sample was seen to be < 10.00 μm.
Key result
Percentile:
D10
Mean:
< 0.147 µm
St. dev.:
0.004
Remarks on result:
other: % STDVP : 2.6
Key result
Percentile:
D50
Mean:
< 5.704 µm
St. dev.:
0.064
Remarks on result:
other: % STDVP : 1.1
Key result
Percentile:
D90
Mean:
< 89.151 µm
St. dev.:
0.465
Remarks on result:
other: % STDVP : 0.5

Standard visual observation

Sample observed to be a very fine, white powder with some medium size particles and clusters.

Observation at 100 x magnification

The particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately < 3.2 μm and the largest individual size was approximately 112 μm.

Observation at 400 x magnification

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

Conclusions:
The mass median aerodynamic diameter was determined to be 6.209 um.

Description of key information

The mass median aerodynamic diameter was determined to be 6.209 um.

Additional information