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Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 15, 2007- February 14, 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to standard ISO guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: BS ISO 13320-1:1999
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of distribution:
volumetric distribution

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): S-500
- Physical state: yellow powder
- Lot/batch No.: MF1456-2345
- Expiration date of the lot/batch: 18 August 2011
- Storage condition of test material: At room temperature in the dark

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
1.452 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
< 0.495 µm
Percentile:
D50
Mean:
< 1.223 µm
Percentile:
D90
Mean:
< 4.343 µm
Particle size distribution at different passages
Size:
< 10 µm
Distribution:
94.69 %

Applicant's summary and conclusion

Conclusions:
The laser diffraction test conducted to determine the particle size analysis resulted in a Mass Median Aerodynamic Diameter of 1.452 µm and 94.69% by volume of the sample was seen to be < 10.00 µm.