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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: ISO 13320 and USP <429>
Deviations:
no
GLP compliance:
no
Type of distribution:
other: Laser diffraction particle size analysis

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
> 155.7 - < 158 µm
Remarks on result:
other: mass median geometric diameter(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Percentile:
D10
Mean:
13.18 - 15.88 µm
St. dev.:
2.7
Percentile:
D50
Mean:
114.3 - 120.1 µm
St. dev.:
5.8
Percentile:
D90
Mean:
359.9 - 393.1 µm
St. dev.:
33.2
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 13 µm
Distribution:
10 %
No.:
#2
Size:
< 111 µm
Distribution:
50 %
No.:
#3
Size:
< 373.1 µm
Distribution:
90 %

Applicant's summary and conclusion

Conclusions:
median particle size 157 µm