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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:
21/07/2017 to 27/07/2017
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)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
No further details specified in the study report.
Mass median aerodynamic diameter:
> 195.476 - < 197.668 µm
Geometric standard deviation:
> 2.602 - < 2.665
Key result
Percentile:
D10
Mean:
47.734 µm
St. dev.:
0.469
Key result
Percentile:
D50
Mean:
184.329 µm
St. dev.:
0.762
Key result
Percentile:
D90
Mean:
480.087 µm
St. dev.:
10.02

Full Test Results

 

RUN 1

RUN 2

RUN 3

RUN 4

RUN 5

Average**

Volumes weighted mean

235.384

232.266

237.275

243.575

232.303

236.161

Median

183.558

184.672

184.385

185.541

183.483

184.329

Mode

208.976

210.448

208.127

208.200

210.321

209.212

MMAD*

195.556

196.743

196.437

197.668

195.476

196.378

D10 – 10% of material is <

47.579

48.449

47.696

47.955

47.018

47.734

D50 – 50% of material is <

183.558

184.672

184.385

185.541

183.483

184.329

D90 – 90% of material is <

479.885

466.951

484.847

496.586

474.147

480.087

All results of 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.

0.83% 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 <

47.579

48.449

47.696

47.955

47.018

0.469

1.0

D50 – 50% of material is <

183.558

184.672

184.385

185.541

183.483

0.762

0.4

D90 – 90% of material is <

479.885

466.951

484.847

496.586

474.147

10.020

2.1

D15.78 – 15.78% of material is <

69.270

70.967

69.880

70.419

68.845

0.764

1.1

GSD

2.650

2.602

2.639

2.635

2.665

0.021

0.8

MMAD

195.556

196.743

196.437

197.668

195.476

0.811

0.4

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

Conclusions:
0.83 % by volume of sample was seen to be < 10.00 μm.
Executive summary:

Particle Size Analysis using dry powder module (DPM)      Average (μm)

Volume weighted mean                                                                 236.161

Median (d.50)                                                                                 184.329

Mode                                                                                              209.212

MMAD (Mass Median Aerodynamic Diameter)                        196.378

10 % of material is <                                                                      47.734

50 % of material is <                                                                      184.329

90 % of material is <                                                                     480.087

by volume of sample was seen to be < 10.00 μm                        0.83 %

Description of key information

Particle Size Analysis using dry powder module (DPM)      Average (μm)

Volume weighted mean                                                                 236.161

Median (d.50)                                                                                 184.329

Mode                                                                                              209.212

MMAD (Mass Median Aerodynamic Diameter)                         196.378

10 % of material is <                                                                      47.734

50 % of material is <                                                                      184.329

90 % of material is <                                                                     480.087

by volume of sample was seen to be < 10.00 μm                        0.83 %

Additional information