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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:
05 April 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of particle tested:
other: Single crystalline particles and agglomerated particles
Type of distribution:
mass based distribution
Test material information:
Composition 1
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature in a dark storeroom.
Mass median aerodynamic diameter:
237.257 µm
Geometric standard deviation:
8.265
Key result
Percentile:
D10
Mean:
< 14.573 µm
St. dev.:
0.143
Key result
Percentile:
D50
Mean:
< 236.784 µm
St. dev.:
3.951
Key result
Percentile:
D90
Mean:
< 542.634 µm
St. dev.:
9.809
No.:
#1
Size:
< 10 µm
Distribution:
< 7.17 %

Table 1: Summary of results

Particle Size Analysis using dry powder module (DPM)

Average (μm)

Volume weighted mean

257.671

Median

236.784

Mode

379.873

MMAD (mass median aerodynamic diameter)

237.257

d10 - 10 % of material is <

14.573

d50 - 50 % of material is <

236.784

d90 - 90 % of material is <

542.634

Volume of sample < 10.00 μm

7.17 %

Optical Microscope Analysis

- Standard visual observation: Sample observed to be a fine to medium, free flowing, white powder with lumps and clusters.

- Observation using 3.2 objective lens: The particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately 3 μm and the largest individual size was approximately 384 μm.

- Observation using 40 objective lens: The sample was observed to be made up of single crystalline particles and agglomerated particles.

Repeatability

Coefficient of variation for d50 was < 3 %; d10 and d90 were less than 5 %. Thus the repeatability of the characteristic particles in the size distribution were within the acceptable limits as per the ISO 13320 -1 test standard.

Conclusions:
Under the conditions of this study the MMAD was 237.257 µm.
Executive summary:

The particle size distribution of the test material was determined in accordance with the standardised guidelines ISO:13320 and CIPAC MT 187, under GLP conditions. The test was performed using laser diffraction.

Under the conditions of this study the MMAD was 237.257 µm. D10 was < 14.573 µm, D50 was < 236.784 µm and D90 was < 542.634 µm. 7.17 % by volume of the sample was seen to be < 10.0 µm.

Repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Description of key information

Under the conditions of this study the MMAD was 237.257 µm.

Additional information

The particle size distribution of the test material was determined in accordance with the standardised guidelines ISO:13320 and CIPAC MT 187, under GLP conditions. The test was performed using laser diffraction.

Under the conditions of this study the MMAD was 237.257 µm. D10 was < 14.573 µm, D50 was < 236.784 µm and D90 was < 542.634 µm. 7.17 % by volume of the sample was seen to be < 10.0 µm.

Repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.