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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:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
The test is conducted in accordance with ISO 13320:2009 “Particle Size Analysis – Laser Diffraction Methods”, 2009 and CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K, 2007.
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
At the request of the sponsor the test item was dried prior to testing. This was performed
by initially vacuum drying by means of a rotary evaporator until the sample had become a
paste. The sample was then placed on trays and allowed to stand under ambient
conditions for 4 days to remove solvent/ moisture. The trays were then placed in drying
ovens at 50°C for 16 hours until constant weight had been achieved.
Mass median aerodynamic diameter:
9.096 µm
Geometric standard deviation:
2.234
Key result
Percentile:
D50
Mean:
6.82 µm
St. dev.:
0.034
Percentile:
D10
Mean:
3.65 µm
St. dev.:
0.01
Percentile:
D90
Mean:
17.1 µm
St. dev.:
0.812

For detailed results (distribution of different passages) see attached file results.

Conclusions:
The mass median aerodynamic diameter (MMAD) of the substance is 9.096 µm, the particle size distribution ranges from 0.01 to 3500 µm. 75.14 % by volume of sample was seen to be < 10.00 μm.
Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%.

Description of key information

The mass median aerodynamic diameter (MMAD) of the substance is 9.096 µm, the particle size distribution ranges from 0.01 to 3500 µm. 75.14 % by volume of sample was seen to be < 10.00 μm.

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%.

Additional information

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