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:
2013-04-08
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:
> 68.95 - < 71.96 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
19.08 - 19.72 µm
St. dev.:
0.64
Percentile:
D50
Mean:
57.85 - 59.96 µm
St. dev.:
2.11
Percentile:
D90
Mean:
136.3 - 144 µm
St. dev.:
7.7
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
< 19 µm
Distribution:
10 %
No.:
#2
Size:
< 58 µm
Distribution:
50 %
No.:
#3
Size:
< 134 µm
Distribution:
90 %

Applicant's summary and conclusion

Conclusions:
median particle size 70 µm