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:
10-29-2018
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:
other: ISO 13320 and USP <429>
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Results and discussion

Mass median aerodynamic diameter:
> 70.85 - < 73.17 µm
Geometric standard deviation:
> 44.79 - < 46.33
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
20 µm
St. dev.:
0.1
Key result
Percentile:
D50
Mean:
64 µm
St. dev.:
2
Key result
Percentile:
D90
Mean:
138 µm
St. dev.:
0.5
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 18.86 µm
Distribution:
10 %
No.:
#2
Size:
< 63.42 µm
Distribution:
50 %
No.:
#3
Size:
< 133.7 µm
Distribution:
90 %

Applicant's summary and conclusion