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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:
From 2014-07-09 to 2014-07-10
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:
2009
Deviations:
no
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 particle tested:
primary particle
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
> 436.576 - < 454.785 µm
Geometric standard deviation:
> 4.61 - < 4.759
Percentile:
D10
Mean:
54.33 µm
St. dev.:
0.28
Remarks on result:
other: Population standard deviation [µm]
Percentile:
D50
Mean:
339.881 µm
St. dev.:
4.95
Remarks on result:
other: Population standard deviation [µm]
Percentile:
D90
Mean:
868.441 µm
St. dev.:
3.59
Remarks on result:
other: Population standard deviation [µm]
No.:
#1
Size:
< 10 µm
Distribution:
0.27 %

MMAD mean: 443 µm (population standard deviation: 6.46 µm)

Mode: 560 µm

 

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:
In a GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187 using the laser diffraction analysis-'wet' small volume dispersion method, the particle size distribution of the substance was determined: 0.27% is< 10.00 µm; 10% is < 54 µm; 50% is < 340 µm and 90% is < 868 µm. The MMAD is 443 µm.
Executive summary:

In a GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187 using the laser diffraction analysis,  

The analysis was conducted using the small volume (wet) module (SVM) with acetone as the dispersant.

The particle size distribution of the substance was determined:  0.27% is< 10.00 µm; 10%  is < 54 µm;  50% is < 340 µm and  90% is < 868 µm. The MMAD is 443 µm.

Description of key information

In a GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187 using the laser diffraction analysis-'wet' small volume dispersion method,  the particle size distribution of the substance was determined:  0.27% is< 10.00 µm; 10%  is < 54 µm;  50% is < 340 µm and  90% is < 868 µm. The MMAD is 443 µm.

Additional information