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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:
2018-10-22
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Qualifier:
according to
Guideline:
other: USP <429>
GLP compliance:
no
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
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: crystalline

Results and discussion

Particle sizeopen allclose all
Percentile:
D10
Mean:
ca. 37 µm
Remarks on result:
other: D50 is the average of 3 measurements, no standard deviation for the average is written
Key result
Percentile:
D50
Mean:
ca. 165 µm
Remarks on result:
other: D50 is the average of 3 measurements, no standard deviation for the average is written
Percentile:
D90
Mean:
ca. 388 µm
Remarks on result:
other: D50 is the average of 3 measurements, no standard deviation for the average is written

Any other information on results incl. tables

Volume Distribution Q3

d10
[µm]

d50
[µm]

d90
[µm]

 

35.76

167.1

377.8

 

34.77

168.8

398.3

 

30.33

159.2

387.9

Mean:

33.62

165.0

388.0

The average of three measurements is:                   

d10:                 37 µm

d50:               165 µm

d90:               388 µm

Applicant's summary and conclusion

Conclusions:
The average particle size (volume distribution) of the test item is d10: 37 µm, d50: 165 µm, d90: 388 µm
Executive summary:

The particle size distribution (volume distribution) of Ceramide VI was measured by laser diffraction in air. The average of three measurements is: d10: 37 µm, d50: 165 µm, d90: 388 µm