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:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Batch Number: 8450
Purity: Approx. 99%
Description: White to pale yellow powder
Expiry date: 28th May 2019

Results and discussion

Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
ca. 20.9 µm
St. dev.:
2.163
Key result
Percentile:
D50
Mean:
ca. 65.5 µm
St. dev.:
2.163
Key result
Percentile:
D90
Mean:
ca. 138 µm
St. dev.:
2.163

Applicant's summary and conclusion

Executive summary:

The granulometry test was performed according to the method ISO 13320 (Particle size analysis - Laser diffraction methods).

The results are the following:

 Particle Size Analysis using dry powder module (DPM)

 Average (μm)

 Volume weighted mean

 73.2

 Median (d.50)

 65.5

 Mode

 84.1

 MMAD (Mass Median Aerodynamic Diameter)

 66.594

 D10

 < 20.9

 D50

 < 65.5

 D90

 <138

with standard deviation of 2.163.