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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:
28 August 2013 - 29 August 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: ISO 13320:2009
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
ca. 1 030.1 - ca. 1 099.12 µm
Geometric standard deviation:
ca. 1.686 - ca. 1.757
Percentile:
D10
Mean:
445.425 µm
St. dev.:
16.55
Remarks on result:
other: Population standard deviation [µm]
Percentile:
D50
Mean:
976.888 µm
St. dev.:
21.95
Remarks on result:
other: Population standard deviation [µm]. Median.
Percentile:
D90
Mean:
1 563.664 µm
St. dev.:
15.9
Remarks on result:
other: Population standard deviation [µm]
No.:
#1
Size:
< 10 µm
Distribution:
0 %

MMAD mean: 1074.57 µm

Mode: 1109.44 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:
The particle size distribution of the substance was determined by laser diffraction analysis-dry powder module (GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187); MMAD= 1075 µm; 0% is < 10 µm; 10% is < 445 µm; 50% is < 977 µm and 90% is < 1564 µm.

Description of key information

The particle size distribution of the substance was determined by laser diffraction analysis-dry powder module (GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187);  MMAD= 1075 µm; 0% is < 10 µm;  10%  is < 445 µm;  50% is < 977 µm and  90% is < 1564 µm.

Additional information