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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:
October 2017 - April 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
yes
Remarks:
For particles <50 µm, the MIE model is recommended for calculation of the particle size. However, since the refractive index was not known, the Fraunhofer model was used.
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
agglomerate
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: 103901

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature (20 ± 5 °C)
- Stability under test conditions: Stable
Remarks on result:
other: MMAD not determined, only laser difraction optical diameters
Key result
Percentile:
D10
Mean:
1.4 µm
Remarks on result:
other: Average
Key result
Percentile:
D50
Mean:
7.2 µm
Remarks on result:
other: Average
Key result
Percentile:
D90
Mean:
16.6 µm
Remarks on result:
other: Average

Test series 1:

D10: 1.4 µm

D50: 7.0 µm (median diameter)

D90: 16.4 µm

 

Test series 2:

D10: 1.4 µm

D50: 7.3 µm (median diameter)

D90: 16.8 µm

 

Average:

D10: 1.4 µm

D50: 7.2 µm (median diameter)

D90: 16.6 µm

Conclusions:
The test item SP02 (trade name: 5OHMIC) has a median particle size D50 = 7 micron, which was determined by laser diffraction measurement and calculated by the Fraunhofer model.
Executive summary:

The test item SP02 (trade name: 5OHMIC) has a median particle size D50 = 7 micron, which was determined by laser diffraction measurement and calculated by the Fraunhofer model.

Description of key information

The test item SP02 (trade name: 5OHMIC) has a median particle size D50 = 7 micron, which was determined by laser diffraction measurement and calculated by the Fraunhofer model.

Additional information