Registration Dossier

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:
07-24-2018
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ISO 13320 and USP <429>
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle

Test material

Test material form:
solid: particulate/powder

Results and discussion

Mass median aerodynamic diameter:
> 61.41 - < 69.43 µm
Geometric standard deviation:
> 37.42 - < 132.6
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
18.29 µm
St. dev.:
0.6
Key result
Percentile:
D50
Mean:
56.97 µm
St. dev.:
8.5
Key result
Percentile:
D90
Mean:
121 µm
St. dev.:
67
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 18.86 µm
Distribution:
10 %
No.:
#2
Size:
< 52.63 µm
Distribution:
50 %
No.:
#3
Size:
< 111 µm
Distribution:
90 %

Applicant's summary and conclusion