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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:
08 November 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
Qualifier:
according to
Guideline:
other: Chilworth Technology Ltd SOP n°417
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 No. of test material: M15KB4494
- Expiration date of the lot/batch: 13 November 2016
- Purity: 99.5% (based on assay)
- Storage condition of test material: Room temperature
Mass median aerodynamic diameter:
4.285 µm
Geometric standard deviation:
>= 1.917 - <= 1.921
Percentile:
D10
Mean:
1.7 µm
St. dev.:
0.004
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:
3.863 µm
St. dev.:
0.011
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:
8.581 µm
St. dev.:
0.028
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 a fine white crystalline solid with clusters and agglomerations.

(2) 100x magnification: particles appeared to be irregular shaped crystals (smallest +/- 3 µm and largest +/- 16 µm)

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

 

Laser Diffraction Particle Size Analysis

Using the identified parameters, the particle size was analysed over the range 0.2 μm to 2000 μm.

The average Volume weighted Mean was 4.622 µm and the mode was 3.953 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 3 µm and 16 µm.
The particle size distribution of T003421 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 4.622 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 4.285 µm, whereas the average D10, D50 and the D90 were determined to be 1.700 µm, 3.863 µm and 8.58 µm, respectively.

Description of key information

The particle size distribution of T003421 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 16 µm. The MMAD was determined to be 4.285 µm, whereas the average D10, D50 and the D90 were determined to be 1.700 µm, 3.863 µm and 8.581 µm, respectively.

Additional information