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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:
14 July 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed in accordance with GLP to a recognised standard
Qualifier:
according to guideline
Guideline:
other: ISO 13320:2009
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
6.817 µm
Geometric standard deviation:
>= 3.213 - <= 3.244
Key result
Percentile:
D50
Mean:
6.249 µm
St. dev.:
1.3
Key result
Percentile:
D10
Mean:
1.188 µm
St. dev.:
0.7
Key result
Percentile:
D90
Mean:
20.447 µm
St. dev.:
1.3
No.:
#1
Size:
< 10 µm
Distribution:
69.51 %

Full Test Results

 

RUN 1

RUN 2

RUN 3

RUN 4

RUN 5

**Average

Volume weighted Mean

9.480

9.711

9.810

9.429

9.786

9.643

Median (d.50)

6.109

6.333

6.318

6.237

6.253

6.249

Mode (μm)

6.768

7.017

7.002

6.925

6.909

6.923

*MMAD

6.664

6.908

6.893

6.803

6.821

6.817

10% of material is <

1.175

1.199

1.196

1.190

1.182

1.188

50% of material is <

6.109

6.333

6.318

6.237

6.253

6.249

90% of material is <

20.209

20.749

20.700

20.106

20.467

20.447

All results are in μm

*Mass Median Aerodynamic Diameter

**Average results is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

69.61% by volume of sample was seen to be < 10.00 μm.

 

Standard Deviation results

Run No.

1

2

3

4

5

STDVP

% STDVP

d10

1.175

1.199

1.196

1.190

1.182

0.009

0.7

d50

6.109

6.333

6.318

6.237

6.253

0.079

1.3

d90

20.209

20.749

20.700

20.106

20.467

0.256

1.3

d15.78

1.888

1.952

1.954

1.941

1.934

0.024

1.2

GSD

3.236

3.244

3.233

3.213

3.233

0.010

0.3

MMAD

6.66

6.91

6.89

6.80

6.82

0.09

1.3

GSD = Geometric standard deviation

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:
69.51 % by volume of sample was seen to be < 10.00 μm.
Executive summary:

Test Objective: 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 benefit of this procedure is that it allows the operator to obtain a better understanding of the particle characterisation of the material. This includes, but is not limited to, sample clusters and agglomerations which may provide false values in the formal particle size analysis. In these situations, where the operator can assess how easily these clusters or agglomerations are dispersed, ultrasonics may be employed. Owing to the extremely small quantities of material used in this analysis it should be noted that discrepancies can arise between the lower and upper limits of the particle size and the actual value obtained in the formal particle size analysis. The test is conducted in accordance with ISO 13320:2009 and CIPAC MT 187.

 

The results of the laser diffraction test conducted to determine the particle size of the sample are summarised in the table below. The analysis was conducted using the dry powder module (DPM).

 

Particle Size Analysis using dry powder module (DPM)

Average (μm)

Volume weighted mean

9.643

Median (d.50)

6.249

Mode

6.923

MMAD (Mass Median Aerodynamic Diameter)

6.817

10% of material is <

1.188

50% of material is <

6.249

90% of material is <

20.447

Volume of sample < 10.00 μm

69.51%

 

69.51 % by volume of sample was seen to be < 10.00 μm.

Description of key information

Key information obtained in a GLP accredited laboratory test.

69.51 % by volume of sample was seen to be < 10.00 μm.

Additional information

Test Objective: 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 analysis was conducted using the dry powder module (DPM). 

69.51 % by volume of sample was seen to be < 10.00 μm.