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Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 Sep 2017
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Mass median aerodynamic diameter:
ca. 205.932 µm
Geometric standard deviation:
ca. 0.36
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
ca. 40.041 µm
St. dev.:
0.452
Key result
Percentile:
D50
Mean:
ca. 207.372 µm
St. dev.:
0.839
Key result
Percentile:
D90
Mean:
ca. 380.229 µm
St. dev.:
2.189

Applicant's summary and conclusion

Conclusions:
During the method development phase of the analysis trials were conducted using the dry powder module (DPM) only. The results of these trials indicated that the most appropriate test and material parameters to obtain the optimum measurements were:
Module : DPM
Dispersant : Air
Dispersion pressure : 0 barg
Refractive index (sample) : 0.000 n
Absorption : 0 AU
Analysis Model : General Purpose (Normal)
Using the identified parameters, the particle size was analysed over the range 0.02 μm to 2000 μm.
The results of the formal analysis are presented in Table 8:1. In addition, a graph of volume (%) versus Particle Diameter (μm), and full particle size distribution, is provided in Graph 8.A (Average of 5 runs).
Executive summary:

The results of the laser diffraction test conducted to determine the particle size of LEE011-B7 are summarised in Table 5:1. The analysis was conducted using the dry powder module (DPM).

Particle Size Analysis using dry powder module (DPM)

 

Average (μm)

Volume weighted mean

 212.755

 Median

 205.932

 Mode

 244.460

MMAD (mass median aerodynamic diameter)

 235.700

d10 - 10 % of material is <

 40.041

d50 - 50 % of material is <

 205.932

d90 - 90 % of material is <

 380.654

volume of sample < 10.00μm

 2.08%