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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:
Nov 14, 2017 to January 12, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Qualifier:
according to
Guideline:
other: CIPAC MT 187 "Particle Size Analysis by Laser Diffraction", Handbook K, 2007
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Test material information:
Composition 1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch No. 648300
- Purity: 99.9%
- Appearance: white to pale yellow crystals
- Relative density: 1.09
Mass median aerodynamic diameter:
184.897 µm
Geometric standard deviation:
>= 2.289 - <= 2.328
Percentile:
D10
Mean:
55.804 µm
St. dev.:
0.6
Key result
Percentile:
D50
Mean:
177.099 µm
St. dev.:
1.212
Percentile:
D90
Mean:
376.276 µm
St. dev.:
3.48

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Standard visual observation: Sample observed to be non-dusting, medium to fine, white to yellow crystals with clusters.

Observation using 3.2 objective lens: The particles appeared to be irregular shaped transparent crystals. the smallest individual particle size was approximately 13 µm and the largest individual size was approximately 512 µm.

Observation using 40 objective lens: The sample was observed to be made up of agglomerated crystalline particles.

Conclusions:
The particle size of the test item was determined using the laser diffraction test. The analysis was conducted using the small volume (wet) module (SVM) with silicone oil as the dispersant. The average MMAD of the test item was reported to be 184.897 µm.

Description of key information

The particle size of the test item was determined using the laser diffraction test. The analysis was conducted using the small volume (wet) module (SVM) with silicone oil as the dispersant. The average mass median aerodynamic diameter (MMAD) of the test item was reported to be 184.897 µm.

Additional information