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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant EC guideline study, performed in recognized contract research organization, no restrictions, fully adequate for assessment.
Qualifier:
according to
Guideline:
other: EUROPEAN COMMISSION, Directorate General XII-JRC, Science Research and Development-Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Guidance Document, ECB/TM/February 1996.
Deviations:
no
Qualifier:
according to
Guideline:
other: EUROPEAN COMMISSION, Directorate General JRC, Joint Research Centre. “Particle Size Distribution, Fibre Length and Diameter Distribution” Draft Guidance Document, EUR 20268 EN (2002), Part 5.2 “Laser scattering / diffraction”.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
other: sieving in combination with laser scattering
Type of distribution:
volumetric distribution
Key result
Percentile:
D50
Mean:
334.9 µm
St. dev.:
3.444
Percentile:
D10
Mean:
62.5 µm
St. dev.:
5.263

The particle size distribution was found to range from approximately 0.3 µm to above 2000 µm (88.2% were <2000 µm).

Particles < 10 µm: 1%, <100 µm: 18%.

The mass median diameter (MMD) was determined to be 334.9 µm (i.e. 50% (by mass) of the particles are smaller than 334.9 µm).

Under the microscope (magnification: 100) pebble-like crystalline structures were observed.

Description of key information

MMD: 335 µm; 1% < 10 µm, 18% < 100 µm (European Commission EUR 20268 EN, 2002; European Commission ECB/TM/Feb. 1996)

Additional information