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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:
Experiment start date - 12 June 2006; Experiment completion date - 15 June 2006; Study completion date - 06 September 2006.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: EUROPEAN COMMISSION, Directorate General XII-JRC, Science Research and Development-Joint Research Centre. "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document, ECB/TM/February 1996
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EUROPEAN COMMISSION, Directorate General JRC, Joint Research Centre. "Particle Size Distribution, Fibre Length and Diameter Distribution" Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 "Laser scattering / diffraction
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
Identity: FAT 40825/A
Batch number: CHU 297 / BOP 04/05
Purity: Organic part (Na-salt): approx. 83.7 %; All coloured components: approx. 80.54 %; Main component: approx. 59.1 %.
Appearance: Solid, black powder
Storage conditions: At room temperature at about 20 °C
Expiration date: December 31, 2010
Percentile:
D50
Mean:
4.6 µm
Remarks on result:
other: 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
No.:
#1
Size:
< 20 µm
Distribution:
100 %
No.:
#2
Size:
< 10 µm
Distribution:
93.85 %
No.:
#3
Size:
< 9 µm
Distribution:
90.25 %
No.:
#4
Size:
< 8 µm
Distribution:
85.02 %
No.:
#5
Size:
< 7 µm
Distribution:
77.72 %
No.:
#6
Size:
< 6 µm
Distribution:
68.05 %
No.:
#7
Size:
< 5 µm
Distribution:
55.58 %
No.:
#8
Size:
< 4 µm
Distribution:
40.88 %
No.:
#9
Size:
< 3 µm
Distribution:
25.24 %
No.:
#10
Size:
< 2 µm
Distribution:
11.19 %
Conclusions:
In conclusion, using the laser diffraction method to study the particle size of FAT 40825/A ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 4.6 µm. The particle size distribution was found to range from approximately 0.3 µm to 20 µm.
Executive summary:

The determination of the particle size distribution of FAT 40825/A was performed according to the European Commission, Document ECB/TM/February 1996: "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document and the EUROPEAN COMMISSION, Directorate General JRC, Joint Research Centre. "Particle Size Distribution, Fibre Length and Diameter Distribution" Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 "Laser scattering / diffraction" using the laser diffraction method. FAT 40825/A is a fine black powder. Under the microscope (with a magnification of 400) small round dark blue globuline structures were observed. A solubility test showed, that the test item is both: sparingly soluble and well dispersible in 2-propanol. The particle size distribution of FAT 40825/A was performed with three samples of the stock dispersion. The results obtained during the measurements showed no relevant difference. Therefore, the study is considered to be valid and no further testing is necessary. In conclusion, using the laser diffraction method to study the particle size of FAT 40825/A ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 4.6 µm. The particle size distribution was found to range from approximately 0.3 µm to 20 µm.

Description of key information

The mass median diameter (MMD) was determined to be 4.6 µm. The particle size distribution was found to range from approximately 0.3 µm to 20 µm.

Additional information

The determination of the particle size distribution of FAT 40825/A was performed according to the European Commission, Document ECB/TM/February 1996: "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document and the EUROPEAN COMMISSION, Directorate General JRC, Joint Research Centre. "Particle Size Distribution, Fibre Length and Diameter Distribution" Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 "Laser scattering / diffraction" using the laser diffraction method. FAT 40825/A is a fine black powder. Under the microscope (with a magnification of 400) small round dark blue globuline structures were observed. A solubility test showed, that the test item is both: sparingly soluble and well dispersible in 2-propanol. The particle size distribution of FAT 40825/A was performed with three samples of the stock dispersion. The results obtained during the measurements showed no relevant difference. Therefore, the study is considered to be valid and no further testing is necessary. In conclusion, using the laser diffraction method to study the particle size of FAT 40825/A ranging between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 4.6 µm. The particle size distribution was found to range from approximately 0.3 µm to 20 µm.