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:
2013-04-09
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: ISO 13320 and USP <429>
Deviations:
no
GLP compliance:
yes
Type of distribution:
volumetric distribution

Test material

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

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
> 333.1 - < 352.7 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
24.54 - 28.39 µm
St. dev.:
3.75
Percentile:
D50
Mean:
258.9 - 280.5 µm
St. dev.:
21.6
Percentile:
D90
Mean:
742.3 - 805.3 µm
St. dev.:
63
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 26 µm
Distribution:
10 %
No.:
#2
Size:
< 267 µm
Distribution:
50 %
No.:
#3
Size:
< 777 µm
Distribution:
90 %

Applicant's summary and conclusion

Conclusions:
median particle size 343 µm