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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
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)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K, 2007
Deviations:
no
GLP compliance:
yes
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Mass median aerodynamic diameter:
11 µm
Geometric standard deviation:
0.013
Key result
Percentile:
D50
Mean:
11 µm
St. dev.:
0.013
No.:
#1
Size:
< 3.05 µm
Distribution:
10 %
No.:
#2
Size:
< 11 µm
Distribution:
50 %
No.:
#3
Size:
< 28 µm
Distribution:
90 %
No.:
#4
Size:
< 10 µm
Distribution:
45.09 %

Particle Size Determination

 

Run 1

Run 2

Run 3

Run 4

Run 5

Average

STDVP

%STDVP

d10 - 10 % of material is <

3.06

3.05

3.05

3.05

3.04

3.05

0.00582

0.191

d50 - 50 % of material is <

11.0

11.0

11.0

10.9

10.9

11.0

0.323

0.294

d90 - 90 % of material is <

28.3

28.1

28.3

27.8

27.9

28.0

0.224

0.797

All results are in µm.

*Mass median aerodynamic diameter. Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

45.09% by volume of sample was seen to be <10.00 µM.

STDVP = Standard deviation of the population.

%STDVP = Percentage standard deviation of the population.

 

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Conclusions:
10% of particulate matter was <3.05 μm
50% of particulate matter was <11.0 μm
90% of particulate matter was <28.0 μm
Executive summary:

The particle size of the test material was conducted in accordance with ISO 13320 (Particle size analysis - Laser diffraction methods). The sample was initially observed to determine whether sieving of the material was required. 5 runs were completed to ensure repeatability of results. During the method development phase of the analysis, trials were conducted using both the dry powder module (DPM) and the small volume (wet) module (SVM). SVM using kerosene was determined to be optimal. The particle size was analysed over the range 0.01 μm to 3500 μm.

 

The results indicated that 10% of particulate matter was <3.05 μm, 50% of particulate matter was <11.0 μm, and 90% of particulate matter was <28.0 μm.

Description of key information

ISO 13320

Additional information

10% of particulate matter was <3.05 μm

50% of particulate matter was <11.0 μm

90% of particulate matter was <28.0 μm