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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:
11 August - 25 August 2015
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
GLP compliance:
yes (incl. certificate)
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:
- Analytical purity: 93.3%
- Batch N°: A14JB3442
- Expiry date: 30 September 2016
- Storage condition: at room temperature
Mass median aerodynamic diameter:
86.556 µm
Geometric standard deviation:
>= 2.804 - <= 2.848
Key result
Percentile:
D10
Mean:
21.652 µm
St. dev.:
0.188
Key result
Percentile:
D50
Mean:
86.556 µm
St. dev.:
0.846
Key result
Percentile:
D90
Mean:
286.901 µm
St. dev.:
2.664

Visual Microscope Analysis

(1) Standard visual observation: sample observed to be fine / medium sized white powder with clusters

(2) 100x magnification: particles appeared to be irregular shaped crystals (smallest +/- 3 µm and largest +/- 624 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

Volume weighted mean was determined to be 123.674 µm.

Average Mode was determined to be 82.356 µm.

The coefficient of variation for d50 was < 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 3 µm and 624 µm.
The particle size distribution of T001036 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 123.674 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 86.556 µm, whereas the average D10, D50 and the D90 were determined to be 21.652 µm, 86.556 µm and 286.901 µm, respectively.

Description of key information

The particle size distribution of T001036 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, 2015). Visual examination at 100x magnification showed irregular shaped crystals between approximately 3 µm and 624 µm. The Mass Median Aerodynamic Diameter (MMAD) was determined to be 86.556 µm. The average D10, D50 and the D90 were determined to be 21.652 µm, 86.556 µm and 286.901 µm, respectively.

Additional information