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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:
12 April - 13 April 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: ISO 13320-1
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 distribution:
volumetric distribution
Specific details on test material used for the study:
Batch M14KB4863
Test item storage conditions: At room temperature
Stable under storage conditions until 10 November 2017 (retest date)
Mass median aerodynamic diameter:
227.239 µm
Geometric standard deviation:
>= 2.374 - <= 2.43
Key result
Percentile:
D10
Mean:
54.776 µm
St. dev.:
1.69
Key result
Percentile:
D50
Mean:
174.284 µm
St. dev.:
4.942
Key result
Percentile:
D90
Mean:
403.551 µm
St. dev.:
9.768

Visual Microscope Analysis

(1) Standard visual observation: sample observed to be a fine to medium, white polydispersed powder with some clusters.

(2) 100x magnification: particles appeared to be irregular shaped crystals (smallest +/- 16 µm and largest +/- 560 µm).

(3) 400x magnification: sample was observed to be made up of single crystalline particles.

Solubility and Dispersability Test

The sample proved to be insoluble and well dispersed in silicone oil. Therefore, silicone oil was used as the suspension fluid.

Laser Diffraction Particle Size Analysis

Average volume weighted mean was determined to be 206.022 µm.

Average mode was determined to be 212.577 µm.

The Coefficient of Variation (CV) for d50 wass <3%. For d10 and d90 it was <5%. Thus the repeatability of the characteristic particles in the size distribution was within the acceptable limits according to the ISO 13320-1 test standard.

Conclusions:
Visual examination at 100x magnification showed irregular shaped crystals between approximately 16 µm and 560 µm.
The particle size distribution of T003063 determined by the laser diffraction method led to the conclusion that the average volume weighted mean
based on 5 runs was 206.022 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 227.239 µm, whereas the average D10, D50 and the D90 were determined to be 54.776 µm, 174.284 µm and 403.551 µm, respectively.

Description of key information

The particle size distribution of T003063 was determined by the laser diffraction method in a Klimisch 1 GLP study according to the Chilworth Technology Ltd SOP n°417, ISO 13320:2009 and CIPAC MT 187 (Chilworth Technology Limited, 2016).

Visual examination at 100x magnification showed irregular shaped crystals between approximately 16 and 560 µm.

The Mass Median Aerodynamic Diameter (MMAD) was determined to be 227.239 µm. The average D10, D50 and the D90 were determined to be 54.776 µm, 174.284 µm and 403.551 µm, respectively.

Additional information