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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:
2017-02-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Qualifier:
according to guideline
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

Constituent 1
Chemical structure
Reference substance name:
2-hydroxy-N-[(2S,3S,4R)-1,3,4-trihydroxyoctadecan-2-yl]benzamide
EC Number:
855-895-8
Cas Number:
212908-67-3
Molecular formula:
C27H47NO5
IUPAC Name:
2-hydroxy-N-[(2S,3S,4R)-1,3,4-trihydroxyoctadecan-2-yl]benzamide
Test material form:
solid: bulk
Details on test material:
Batch EP15C02132
Benzamide,N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-2-hydroxy-

Results and discussion

Particle sizeopen allclose all
Percentile:
D10
Mean:
ca. 4 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. 29 µm
Remarks on result:
other: D50 is the average of 3 measurements, no standard deviation for the average is written
Percentile:
D90
Mean:
ca. 107 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]

 

3.480

24.72

87.98

 

3.933

26.53

99.40

 

4.587

35.08

132.2

Mean:

4.000

28.78

106.5

The average of three measurements is:                   

d10:                 4 µm

d50:               29 µm

d90:               107 µm

Applicant's summary and conclusion

Conclusions:
The average particle size (volume distribution) of the test item is d10: 4 µm, d50: 29 µm, d90: 107 µm.
Executive summary:

The particle size distribution (volume distribution) of Phytosphingosine SLC was measured by laser diffraction in n-Heptane. The average of three measurements is: d10: 4 µm, d50: 29 µm, d90: 107 µm.