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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:
The experimental start date was 14 May 2019, and the experimental completion date was 16 May 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:
Particle Size Analysis – Laser Diffraction Methods. 2009.
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Version / remarks:
Particle Size Analysis by Laser Diffraction, Handbook K. 2007.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle

Test material

Constituent 1
Chemical structure
Reference substance name:
(2S,3S)-2-benzhydryl-N-[(5-tert-butyl-2-methoxy-phenyl)methyl]quinuclidin-3-amine
EC Number:
831-973-7
Cas Number:
147116-67-4
Molecular formula:
C32H40N2O
IUPAC Name:
(2S,3S)-2-benzhydryl-N-[(5-tert-butyl-2-methoxy-phenyl)methyl]quinuclidin-3-amine
Test material form:
solid
Details on test material:
White to off-white powder.
Storage Conditions: At room temperature.

Results and discussion

Mass median aerodynamic diameter:
ca. 50.9 µm
Geometric standard deviation:
ca. 2.943
Particle sizeopen allclose all
Percentile:
D10
Mean:
ca. 12.1 µm
St. dev.:
0.034
Percentile:
D50
Mean:
ca. 47.7 µm
St. dev.:
0.723
Percentile:
D90
Mean:
ca. 141 µm
St. dev.:
2.04

Applicant's summary and conclusion