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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:
25 January 2017 - 26 January 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Chilworth Technology Ltd SOP n°417
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
- Batch n°: I16CB1581
- Analytical purity: >99.9% (based on HPLC with impurities of 0.1%)
- Expiration date: 04 April 2019
- Storage condition: at room temperature
Mass median aerodynamic diameter:
7.638 µm
Geometric standard deviation:
>= 2.435 - <= 2.446
Percentile:
D10
Mean:
2.111 µm
St. dev.:
0.02
Remarks on result:
other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
Key result
Percentile:
D50
Mean:
6.599 µm
St. dev.:
0.06
Remarks on result:
other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
Percentile:
D90
Mean:
22.205 µm
St. dev.:
0.213
Remarks on result:
other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

Visual Microscope Analysis

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

(2) 100x magnification: particles appeared to be irregular shaped crystals (smallest +/- 3 µm and largest +/- 26 µm)

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

 

Solubility and Dispersability Test

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

 

Laser Diffraction Particle Size Analysis

Using the identified parameters, the particle size was analysed over the range 0.02 μm to 2000 μm.

The average Volume weighted Mean was 10.569 µm and the mode was 6.250 µm. The Coefficient of Variation for d50 was <3%; d10 and d90 were <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 3µm and 26µm.
The particle size distribution of T003066 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 10.569 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 7.638 µm, whereas the average D10, D50 and the D90 were determined to be 2.111 µm, 6.599 µm and 22.205 µm, respectively.

Description of key information

The particle size distribution of T003066 was determined by the laser diffraction method in a GLP study according to Chilworth Technology Ltd SOP n°417, ISO 13320:2009 and CIPAC MT 187 (Livingston, 2017). The visual examination at 100x magnification showed irregular shaped crystals between approximately 3µm and 26µm. The MMAD was determined to be 7.638 µm, whereas the average D10, D50 and the D90 were determined to be 2.111 µm, 6.599 µm and 22.205 µm, respectively.

Additional information

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