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Physical & Chemical properties

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:
22 April 2014 to 11 September 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
no
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:
Test substance: FAT 40075/D
Batch Number: BS-1113243
Percentile:
D10
Mean:
1.9 µm
Remarks on result:
other: Std deviation not specified
Key result
Percentile:
D50
Mean:
5.77 µm
Remarks on result:
other: Std deviation not specified
Percentile:
D90
Mean:
12 µm
Remarks on result:
other: Std deviation not specified
Conclusions:
The mass median diameter was found to be 5.77 µm.
Executive summary:

The particle size distribution of FAT 40075/D was determined according to CIPAC MT 187 by laser diffraction method with dry dispersion. Malvern Mastersizer 2000 was used for determination of particle size distribution. An appropriate amount of the particles of the test item were introduced to the analyser beam (Helium-Neon Laser) by direct spraying through the measurement area using the dry powder feeder. By altering the air pressure and feeding rate the optimum measuring conditions were found. The dispersing energy was chosen in a way that the particle size distribution was nearly constant with increasing energy. The particle size distribution was determined twice and the average result is given. Based on the findings of the study, the mass median diameter was found to be 5.77 µm whereas L10D and L90D were 1.90 and 12.0 µm, respectively.

Description of key information

The mass median (aerodynamic) diameter was found to be 5.77 µm.

Additional information

The particle size distribution of FAT 40075/D was determined according to CIPAC MT 187 by laser diffraction method with dry dispersion. Malvern Mastersizer 2000 was used for determination of particle size distribution. An appropriate amount of the particles of the test item were introduced to the analyser beam (Helium-Neon Laser) by direct spraying through the measurement area using the dry powder feeder. By altering the air pressure and feeding rate the optimum measuring conditions were found. The dispersing energy was chosen in a way that the particle size distribution was nearly constant with increasing energy. The particle size distribution was determined twice, and the average result is given. Based on the findings of the study, the mass median diameter was found to be 5.77 µm whereas L10D and L90D were 1.90 and 12.0 µm, respectively.