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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:
9 July 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed to ISO standard in accordance with GLP and reported with a GLP certificate.
Qualifier:
according to guideline
Guideline:
other: ISO 13320:2009
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
0.777 µm
Geometric standard deviation:
> 1.782 - < 1.785
Percentile:
D50
Mean:
0.731 µm
St. dev.:
0.002
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D50
Mean:
0.731 µm
St. dev.:
0.002
Percentile:
D10
Mean:
< 0.355 µm
St. dev.:
0.001
Percentile:
D90
Mean:
< 2.319 µm
St. dev.:
0.104

Full Test Results

 

RUN 1

RUN 2

RUN 3

RUN 4

RUN 5

**Average

Volume weight Mean

1.428

1.434

1.432

1.438

1.435

1.433

Median (d.50)

0.729

0.731

0.730

0.732

0.731

0.731

Mode (μm)

0.678

0.678

0.678

0.679

0.678

0.678

*MMAD

0.775

0.777

0.776

0.779

0.777

0.777

10% of material is <

0.355

0.355

0.355

0.356

0.355

0.355

50% of material is <

0.729

0.731

0.730

0.732

0.731

0.731

90% of material is <

2.256

2.315

2.315

2.360

2.357

2.319

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.

97.78% by volume of sample was seen to be < 10.00 μm

 

Standard Deviation Results

Run No.

1

2

3

4

5

STDVP

%STDVP

d10

0.355

0.355

0.355

0.356

0.355

0.000

0.1

d50

0.729

0.731

0.730

0.732

0.731

0.001

0.1

d90

2.256

2.315

2.312

2.360

2.357

0.038

1.6

d15.78

0.409

0.410

0.409

0.410

0.410

0.000

0.1

GSD

1.782

1.783

1.785

1.785

1.783

0.001

0.1

MMAD

0.78

0.78

0.78

0.78

0.78

0.00

0.2

GSD = Geometric standard deviation

STDVP = standard deviation of the population

% STDVP = percentage standard deviation of the population

Conclusions:
97.78 % by volume of sample was seen to be < 10.00 μm.
Executive summary:

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).

97.78 % by volume of sample was seen to be < 10.00 μm.

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.

 

Summary of results

Particle Size Analysis using dry powder module (DPM)

Average (μm)

Volume weighted mean

1.433

Median (d.50)

0.731

Mode

0.678

MMAD (Mass Median Aerodynamic Diameter)

0.777

10% of material is <

0.355

50% of material is <

0.731

90% of material is <

2.319

Volume of sample < 10.00 μm

97.78%

 

Description of key information

Key value determined at a GLP accredited laboratory.

97.78 % by volume of sample was seen to be < 10.00 μm.

Additional information

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