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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:
07 November 2011-17 November 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to appropriate guidelines and according to the principles of GLP.
Qualifier:
according to guideline
Guideline:
other: The test was conducted in accordance with ISO 13320:2009 and CIPAC MT 187 and took into consideration OECD guideline 110
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
126.568 µm
Percentile:
D10
Mean:
7.401 µm
St. dev.:
1.81
Remarks on result:
other: Average of 5 runs
Percentile:
D50
Mean:
102.324 µm
St. dev.:
2.65
Remarks on result:
other: Average of 5 runs
Percentile:
D90
Mean:
351.112 µm
St. dev.:
2.12
Remarks on result:
other: Average of 5 runs
No.:
#1
Size:
< 10 µm
Distribution:
12.23 %

Volume weighted Mean: 146.039 µm (average of 5 runs)


Mode: 177.718 µm (average of 5 runs)


Coefficient of variation for d50 is less than 3 %; d10 and d90 are less than 5 %. Thus, repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Conclusions:
Particle Size Analysis (laser diffraction-wet' small volume module) results for FAT 41043/A:
MMAD= 126.568 µm; 10 % is <7.401 µm; 12.23 % is <10 µm; 50 % is <102.324 µm and 90 % is <351.112 µm.

Description of key information

MMAD= 126.568 µm; D50= 102.324 µm; D10= 7.401 µm and D90= 351.112 µm (Laser diffraction analysis-'wet' small volume dispersion method).

Additional information

12.23% by volume is < 10 µm