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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:
5 July 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: ISO 13320-1
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 distribution:
volumetric distribution
Specific details on test material used for the study:
- Batch n°: I15FB3131
- Analytical purity: 100% (based on base titration)
- Expiration date: 11 June 2017
- Storage condition: at room temperature
Mass median aerodynamic diameter:
597.669 µm
Geometric standard deviation:
>= 1.776 - <= 1.815
Percentile:
D10
Mean:
238.427 µm
St. dev.:
4.581
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:
520.204 µm
St. dev.:
3.859
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:
968.907 µm
St. dev.:
5.094
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 polydispersed, gritty, free flowing white powder.

(2) 100x magnification: particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately 3 μm and the largest individual size was approximately 832 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 0.02μm to 2000μm.

The average Volume weighted Mean was 564.395µm and the mode was 560.459µm. 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 the sample to be irregular shaped crystals between approximately 3µm and 832µm.
The particle size distribution of T001141 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 564.395 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 597.669µm, whereas the average D10, D50 and the D90 were determined to be 238.427 µm, 520.204µm and 968.907µm, respectively.

Description of key information

The particle size distribution of T001141 was determined by the laser diffraction method in a GLP study according to the methods ISO 13320:2009 and CIPAC MT 187 (Livingston, 2016). The visual examination at 100x magnification showed irregular crystals  of dimensions between 3 µm and 832µm approximately. The MMAD (mass median aerodynamic diameter) was determined to be 597.669µm, whereas the average D10, D50 and the D90 were determined to be 238.427 µm, 520.204 µm and 968.907 µm, respectively.

Additional information