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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
Study period:
06/02/2018 to 07/02/2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
ISO 13320:2009 “Particle Size Analysis – Laser Diffraction Methods”, 2009
Deviations:
not specified
Principles of method if other than guideline:
The test is conducted in accordance with CIPAC MT 187 “Particle Size Analysis by Laser Diffraction”, Handbook K, 2007.
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
counted distribution
Specific details on test material used for the study:
No further details specified in the study report.
Mass median aerodynamic diameter:
>= 25.165 - <= 25.961 µm
Geometric standard deviation:
2.573
Key result
Percentile:
D50
Mean:
24.15 µm
St. dev.:
0.297

Full Test Results

 

RUN1

RUN2

RUN3

RUN4

RUN5

Average**

Volume weighted mean

31.022

31.018

30.938

30.798

30.690

30.893

Median

24.418

24.442

24.173

23.684

23.882

24.120

Mode

28.194

28.144

27.525

26.366

26.955

27.447

MMAD*

25.945

25.971

25.685

25.165

25.376

25.629

d10 – 10% of material is <

7.096

7.080

7.047

6.847

6.938

7.000

d50 – 50% of material is <

24.418

24.442

24.173

23.684

23.882

24.120

d90 – 90% of material is <

65.212

65.161

65.242

65.860

65.022

65.297

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.

17.37 % by volume of sample was seen to be < 10.00 μm

 

Standard Deviation Results

Run No.

1

2

3

4

5

STDVP

%STDVP

d10 – 10% of material is <

7.096

7.080

7.047

6.847

6.938

0.095

1.4

d50 – 50% of material is <

24.418

24.442

24.173

23.684

23.882

0.297

1.2

d90 – 90% of material is <

65.212

65.161

65.242

65.860

65.022

0.290

0.4

d15.78 – 15.78 % of material is <

9.501

9.509

9.423

9.153

9.287

0.137

1.5

GSD

2.570

2.570

2.565

2.588

2.572

0.008

0.3

MMAD

25.945

25.971

25.685

25.165

25.376

0.316

1.2

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 ISO 13320-1 test standard.

Conclusions:
Particle Size Analysis using dry powder module (DPM) Average (μm)
Volume weighted mean 30.893
Median (d.50) 24.150
MMAD (Mass Median Aerodynamic Diameter) 25.629
Executive summary:

To characterise the particle size distribution of the powder. The analysis is conducted initially using a visual microscope and is then undertaken more formally using a Laser Diffraction Particle Size Analyser.

 

The test is conducted in accordance with ISO 13320:2009 “Particle Size Analysis – Laser Diffraction Methods”, 2009.

 

Using the identified parameters, the particle size was analysed over the range 0.02 μm to 2000 μm.

 

Particle Size Analysis using dry powder module (DPM)

Average (μm)

Volume weighted mean

30.893

Median (d.50)

24.150

Mode

27.447

MMAD (Mass Median Aerodynamic Diameter)

25.629

10 % of material is <

7.000

50 % of material is <

24.120

90 % of material is <

65.297

by volume of sample was seen to be < 10.00 μm

17.37%

 

Description of key information

 

Particle Size Analysis using dry powder module (DPM)

Average (μm)

Volume weighted mean

30.893

Median (d.50)

24.150

MMAD (Mass Median Aerodynamic Diameter)

25.629

 

Additional information

To characterise the particle size distribution of the powder. The analysis is conducted initially using a visual microscope and is then undertaken more formally using a Laser Diffraction Particle Size Analyser.

Using the identified parameters, the particle size was analysed over the range 0.02 μm to 2000 μm.

 

Particle Size Analysis using dry powder module (DPM)

Average (μm)

Volume weighted mean

30.893

Median (d.50)

24.150

Mode

27.447

MMAD (Mass Median Aerodynamic Diameter)

25.629

10 % of material is <

7.000

50 % of material is <

24.120

90 % of material is <

65.297

by volume of sample was seen to be < 10.00 μm

17.37%