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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:
11 August 2016 to 15 September 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
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:
1.358 µm
Geometric standard deviation:
>= 1.757 - <= 1.762
Key result
Percentile:
D10
Mean:
0.353 µm
St. dev.:
0
Key result
Percentile:
D50
Mean:
0.716 µm
St. dev.:
0.001
Key result
Percentile:
D90
Mean:
1.622 µm
St. dev.:
0.007

Full test results:

 

RUN 1

RUN 2

RUN 3

RUN 4

RUN 5

**Average

Volume weighted mean

1.047

1.038

1.039

1.037

1.034

1.039

Median (d50)

0.717

0.716

0.716

0.715

0.715

0.716

Mode (um)

0.687

0.688

0.687

0.687

0.687

0.687

*MMAD

1.360

1.359

1.359

1.357

1.357

1.358

10% of material is <

0.353

0.353

0.353

0.353

0.353

0.353

50% of material is <

0.717

0.716

0.716

0.715

0.715

0.716

90 % of material is <

1.635       

1.621

1.623  

1.617

1.614

1.622

AII results are in um

* Mass Median Aerodynamic Diameter

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

99.56 % by volume of sample was seen to be < 10.00μm.

Standard deviation results:

Run No.

1

2

3

4

5

STOVP

% STOVP

d10

0.353

0.353

0.353

0.353

0.353

0.000

0.0

d50

0.717

0.716

0.716

0.715

0.715

0.001

0.1

d90

1.635

1.621

1.623

1.617

1.614

0.007

0.4

d15.78

0.407

0.407

0.407

0.407

0.407

0.000

0.0

GSD

1.762

1.759

1.759

1.757

1.757

0.002

0.1

MMAD

1.36

1.36

1.36

1.36

1.36

0.00

0.1

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:
In a laser diffraction test conducted in accordance with GLP, the mass median aerodynamic diameter (MMAD) was found to be 1.358 um. 90% of the material was < 1.622 um.

Description of key information

In a laser diffraction test (conducted in accordance with GLP), the mass median aerodynamic diameter (MMAD) was found to be 1.358 um and 90% of the material was < 1.622 um.

Additional information