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Physical & Chemical properties

Particle size distribution (Granulometry)

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Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-02-27
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
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:
9-Octadecenamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-, (9Z)-
EC Number:
812-963-1
Cas Number:
178436-06-1
Molecular formula:
C36H71NO4
IUPAC Name:
9-Octadecenamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-, (9Z)-
Test material form:
solid

Results and discussion

Particle sizeopen allclose all
Percentile:
D10
Mean:
ca. 14 µm
St. dev.:
1.49
Key result
Percentile:
D50
Mean:
ca. 87 µm
St. dev.:
22.71
Percentile:
D90
Mean:
ca. 257 µm
St. dev.:
115.46

Any other information on results incl. tables

Volume Distribution Q3

d10
[µm]

d50
[µm]

d90
[µm]

 

15.58

119.5

419.7

 

12.05

71.18

167.3

 

13.00

71.47

183.0

Mean:

13.54

87.38

256.7

The average of three measurements is:                   

d10:                 14 µm

d50:               87 µm

d90:               257 µm

Applicant's summary and conclusion

Conclusions:
The average particle size (volume distribution) of the test item is d10: 14 µm, d50: 87 µm, d90: 257 µm
Executive summary:

The particle size distribution (volume distribution) of Ceramide III was measured by laser diffraction in n-Heptane. The average of three measurements is: d10: 14 µm, d50: 87 µm, d90: 257 µm