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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 February 2016
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
GLP compliance:
yes (incl. QA statement)
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:
- Batch n°:I15FC2164
- Expiration date: 23 June 2017
- Purity:102.2% (based on HPLC)
- Storage condition of test material:at room temperature
Mass median aerodynamic diameter:
6.369 µm
Geometric standard deviation:
>= 2.111 - <= 2.453
Percentile:
D10
Mean:
1.755 µm
St. dev.:
0.015
Percentile:
D50
Mean:
5.218 µm
St. dev.:
0.025
Percentile:
D90
Mean:
11.676 µm
St. dev.:
0.113

Visual Microscope Analysis

(1) Standard visual observation: sample observed to be a fine and medium, light brown powder with lumps and clusters.

(2) 100x magnification: particles appeared to be needles / fibre crystals (smallest +/- 3 µm and largest +/- 19 µm).

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

Laser Diffraction Particle Size Analysis

Average volume weighted mean was determined to be 6.309 µm.

Average mode was determined to be 5.587 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 needles / fibre crystals between approximately 3 µm and 19 µm.
The particle size distribution of T002488 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 6.309 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 6.369 µm, whereas the average D10, D50 and the D90 were determined to be 1.755 µm, 5.218 µm and 11.676 µm, respectively.

Description of key information

The particle size distribution of T002488 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 needles / fibre crystals between approximately 3 µm and 19 µm.

The Mass Median Aerodynamic Diameter (MMAD) was determined to be 6.369 µm. The average D10, D50 and the D90 were determined to be 1.755 µm, 5.218 µm and 11.676 µm, respectively.

Additional information