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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:
27th June 2019 to 28th June 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187 ''Particle Size Analysis by Laser Diffraction'' Handbook K
Version / remarks:
2007
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction

Test material

Constituent 1
Chemical structure
Reference substance name:
3-tert-butyl-1-(3,5-dicarboxyphenyl)-1H-pyrazol-5-aminium chloride
EC Number:
941-661-3
Molecular formula:
C15H18ClN3O4
IUPAC Name:
3-tert-butyl-1-(3,5-dicarboxyphenyl)-1H-pyrazol-5-aminium chloride
impurity 1
Reference substance name:
Unidentified impurity
IUPAC Name:
Unidentified impurity

Results and discussion

Mass median aerodynamic diameter:
ca. 92.6 µm
Geometric standard deviation:
ca. 1.616
Particle sizeopen allclose all
Percentile:
D50
Mean:
80.7 µm
St. dev.:
0.161
Remarks on result:
other: median
Percentile:
D10
Mean:
43.4 µm
St. dev.:
0.193
Percentile:
D90
Mean:
135 µm
St. dev.:
0.852
Particle size distribution at different passages
No.:
#1
Size:
< 100 µm
Distribution:
0.21 %
Remarks on result:
other: by volume of sample

Applicant's summary and conclusion

Conclusions:
MMAD 92.6 µm