Registration Dossier

Diss Factsheets

Physical & Chemical properties

Particle size distribution (Granulometry)

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 7, 2014 - March 24, 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study has been performed in accordance with the ISO 13320 and CIPAC MT 187 guidelines and complied with the principles of GLP.
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 particle tested:
primary particle
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
31.877 - 31.986 µm
Geometric standard deviation:
1.382
Key result
Percentile:
D10
Mean:
11.264 µm
St. dev.:
0.018
Remarks on result:
other: Population standard deviation [µm]
Key result
Percentile:
D50
Mean:
16.949 µm
St. dev.:
0.024
Remarks on result:
other: Population standard deviation [µm]. Median.
Key result
Percentile:
D90
Mean:
25.381 µm
St. dev.:
0.034
Remarks on result:
other: Population standard deviation [µm]
No.:
#1
Size:
< 10 µm
Distribution:
4.51 %

MMAD mean: 31.934 µm

Mode mean: 16.999 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= 31.9 µm; 10% is < 11.3 µm; 4.5% is < 10.00 µm; 50% is < 16.9 µm and 90% is < 25.4 µm.

Description of key information

The MMAD of the substance was determined to be 31.9 µm. 4.5% by volume was found to be < 10 µm. The d90 was 25.4 µm.

Additional information

The particle size distribution of a sample of the substance was determined by laser diffraction analysis-dry powder module (GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187).