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Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 Mar 2021 to 10 Mar 2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
ISO 13320-1
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Key result
Percentile:
D10
Mean:
0.725 µm
St. dev.:
0.29
Key result
Percentile:
D50
Mean:
18.33 µm
St. dev.:
0.29
Key result
Percentile:
D90
Mean:
50.33 µm
St. dev.:
0.29
Key result
Percentile:
other: D4,3,
Mean:
22.14
St. dev.:
0.29
Remarks on result:
other: The mass moment męan (De Brouckere Mean Diameter)









































































Particles size



 



Test number and fraction size [um]



1



2



3



4



5



Average



 



 



 



d10 [um]



0.732



0.731



0.727



0.719



0.715



0.725



d50 [ pm]



18.36



18.49



18.47



18.19



18.15



18.33



d90 [pm]



50.37



51.07



51.01



49.65



49.54



50.33



* d4,3, [pm]



22.19



22.47



22.37



21.87



21.82



22.14



Average (143, [um]



 



22.14



Standard deviation, [Yim]



 



0.29



Relative Standard Deviation, [0/0]



 



1.32%



* Average d43, [gm] — The mass moment mean (De Brouckere Mean Diameter)

Conclusions:
The averade particle size of the test item is D10 = 0.725 µm, D50 = 18,33 µm, D90 = 50.33 µm and D4,3, = 22.14 µm (Mass moment mean - De Brouckere Mean Diameter)
Executive summary:

The particle size distribution was determined in accordance with ISO 13320-1 and CIPAT MT 187 under GLP conditions. 0.5g of test item were disperes in 10ml of 10% Tween80 and place into the laser diffration apparatus Coulter 13 320. After the appropriate concentration was reached, signalled by the system, the measurment was started. The results were registered in graphical and numerical forms. The averade particle size of the test item is D10 = 0.725 µm, D50 = 18,33 µm, D90 = 50.33 µm and D4,3, = 22.14 µm (Mass moment mean - De Brouckere Mean Diameter)

Description of key information

Key study, Method according to ISO 13320-1 and CIPAC MT 187, GLP study. The averade particle size of the test item is D10 = 0.725 µm, D50 = 18,33 µm, D90 = 50.33 µm and D4,3, = 22.14 µm (Mass moment mean - De Brouckere Mean Diameter)

Additional information

The particle size distribution was determined in accordance with ISO 13320-1 and CIPAT MT 187 under GLP conditions. 0.5g of test item were disperes in 10ml of 10% Tween80 and place into the laser diffration apparatus Coulter 13 320. After the appropriate concentration was reached, signalled by the system, the measurment was started. The results were registered in graphical and numerical forms. The averade particle size of the test item is D10 = 0.725 µm, D50 = 18,33 µm, D90 = 50.33 µm and D4,3, = 22.14 µm (Mass moment mean - De Brouckere Mean Diameter)