Registration Dossier

Physical & Chemical properties

Particle size distribution (Granulometry)

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
GLP compliance:
no
Other quality assurance:
other: ISO 9001-2008
Type of method:
Laser scattering/diffraction
Type of particle tested:
agglomerate
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
0.725 mm
Geometric standard deviation:
0.54
Key result
Percentile:
D10
Mean:
26.58 µm
Remarks on result:
other: st. dev. not determined
Key result
Percentile:
D50
Mean:
696.8 µm
Remarks on result:
other: st. dev. not determined
Key result
Percentile:
D90
Mean:
1 495 µm
Remarks on result:
other: st. dev. not determined

Part of the sample is out of the measurement range of the instrument.

Conclusions:
The mass median diameter of the particles is 724.5 μm (st. dev. 542.6 μm)

Description of key information

The particle size determination is done by means of laser diffraction analysis.

The mass median diameter of the particles determined by laser diffraction analysis is 724.5 μm: the powder is considered to be of low/medium volatility.

Additional information