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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:
30 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
Storage condition: Controlled room temperature in a dark storeroom.
Mass median aerodynamic diameter:
79.033 µm
Geometric standard deviation:
0.4
Key result
Percentile:
D50
Mean:
< 72.541 µm
St. dev.:
0.7
Remarks on result:
other: St. dev is a %
No.:
#1
Size:
< 10 µm
Distribution:
10.7 %

Table 1: Full test results

 

RUN 1

RUN 2

RUN 3

RUN 4

RUN 5

Average**

Volume weighted mean

87.761

87.465

86.633

87.494

88.724

87.616

Median

72.429

72.646

71.800

72.407

73.441

72.541

Mode

110.697

111.185

108.824

109.177

110.865

110.130

MMAD*

78.911

79.148

78.226

78.887

80.014

79.033

d10 - 10 % of material is <

9.423

9.473

9.387

9.405

9.478

9.433

d50 - 50 % of material is <

72.429

72.646

71.800

72.407

73.441

72.541

d90 - 90 % of material is <

191.243

189.887

188.257

190.270

192.250

190.385

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.

10.70 % by volume of sample was seen to be < 10.00 μm.

 

Table 2: Standard deviation results

 

RUN 1

RUN 2

RUN 3

RUN 4

RUN 5

STDVP

% STDVP

d10 - 10 % of material is <

9.423

9.473

9.387

9.405

9.478

0.036

0.4

d50 - 50 % of material is <

72.429

72.646

71.800

72.407

73.441

0.529

0.7

d90 - 90 % of material is <

191.243

189.887

188.257

190.270

192.250

1.342

0.7

d15.78 - 15.78 % of material is <

14.665

14.768

14.583

14.636

14.773

0.075

0.5

GSD

4.939

4.919

4.924

4.947

4.971

0.019

0.4

MMAD

78.911

79.148

78.226

78.887

80.014

0.577

0.7

GSD = Geometric standard deviation of the lognormal particle size distribution (calculated from d50/d15.78)

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 test standard.

Conclusions:
Under the conditions of the study the MMAD was 79.033 µm and the D50 was 72.541 µm.
Executive summary:

The particle size of the test material was determined in accordance with the standardised guideline ISO:133220 under GLP conditions using microscopic examination and laser diffraction.

Following solubility testing it was determined that acetone would be used as a dispersant for the test material. The particle size was analysed over the range 0.02 μm to 2 000 μm and 5 runs were performed to ensure reliability of results.

Coefficient of variation for D50 was 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 test standard.

The volume of sample < 10 µm was 10.7 %.

Under the conditions of the study the MMAD of the test material was 79.033 µm and the D50 was 72.541 µm.

Description of key information

Under the conditions of the study the MMAD of the test material was 79.033 µm and the D50 was 72.541 µm.

Additional information

The particle size of the test material was determined in accordance with the standardised guideline ISO:133220 under GLP conditions using microscopic examination and laser diffraction.

Following solubility testing it was determined that acetone would be used as a dispersant for the test material. The particle size was analysed over the range 0.02 μm to 2 000 μm and 5 runs were performed to ensure reliability of results.

Coefficient of variation for D50 was 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 test standard.

The volume of sample < 10µm was 10.7 %.

Under the conditions of the study the MMAD of the test material was 79.033 µm and the D50 was 72.541 µm.