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Diss Factsheets

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 18 Apr 2019 and the experimental completion date was 19 Apr 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:
aggregate

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
444-810-6
EC Name:
-
Molecular formula:
C27 H30 N2 * C10 H16 O4 S
IUPAC Name:
(2S-cis)-(diphenylmethyl)-N-(phenylmethyl)-1-azabicyclo[2.2.2.]octan-3-amine (1-R camphor-10-sulfonate)
Test material form:
solid: particulate/powder

Results and discussion

Mass median aerodynamic diameter:
ca. 3.27 µm
Geometric standard deviation:
ca. 1.796
Particle sizeopen allclose all
Key result
Percentile:
D50
Mean:
ca. 2.94 µm
St. dev.:
0.006
Key result
Percentile:
D10
Mean:
ca. 1.65 µm
St. dev.:
0.003
Key result
Percentile:
D90
Mean:
ca. 0.157 µm
St. dev.:
6.98

Any other information on results incl. tables

Test results

 

Run 1

Run 2

Run 3

Run 4

Run 5

Mean

STDVP

%STDVP

Volume weighted mean

3.98

3.98

3.92

3.96

3.90

3.95

0.0358

0.906

Mode

2.54

2.55

2.56

2.57

2.58

2.56

0.0132

0.515

d10 (10% of material is <)

1.65

1.65

1.65

1.66

1.66

1.65

0.00265

0.160

d50 (50% of material is <)

2.95

2.95

2.94

2.94

2.94

2.94

0.00632

0.215

d90 (90% of material is <)

7.17

7.11

6.92

6.92

6.78

6.98

0.157

2.25

GSD

1.807

1.805

1.789

1.797

1.781

1.796

0.011

0.610

MMAD

3.27

All results are in µm.

Applicant's summary and conclusion

Conclusions:
The particle size distribution of the test item was determined by means of Laser Diffraction Analysis using the medium volume (wet) module (MVM).
The D50 of the test item was determined to be 2.94 µm, the D10 was 1.65 µm and the D90 was 6.98 µm. The MMAD of the test item was calculated to be 3.27 µm.
Executive summary:

The D50 of the test item was determined to be 2.94 µm, the D10 was 1.65 µm and the D90 was 6.98 µm.

The MMAD of the test item was calculated to be 3.27 µm.

The GSD of the test item was calculated to be 1.796 µm.