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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:
21 JUL 2020 to 14 AUG 2020
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
not applicable
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Percentile:
D10
Mean:
ca. 17 - ca. 23.2 µm
Remarks on result:
other: not more information available
Percentile:
D50
Mean:
ca. 50.6 - ca. 60.5 µm
Remarks on result:
other: not more information available
Percentile:
D90
Mean:
ca. 103 - ca. 123 µm
Remarks on result:
other: not more information available
Conclusions:
The particles have a size for d10 with 17-23.2 µm, for d50 with 50.6-60.5 µm and for d90 with 103-123 µm.
Executive summary:

The particle size distribution of the test item was assessed by the sponsor in an in-house non-GLP test via laser diffraction with a Malvern device. The procedure is similar to ISO 13320. It was observed, that the particles have the following sizes and are not existing as nanomaterial:

d10: 17-23.2 µm

d50: 50.6-60.5 µm

d90: 103-123 µm.

Description of key information

The particle size distribution of the test item was assessed by the sponsor in an in-house non-GLP test via laser diffraction with a Malvern device. The procedure is similar to ISO 13320. It was observed, that the particles have the following sizes and are not existing as nanomaterial:

d10: 17-23.2 µm

d50: 50.6-60.5 µm

d90: 103-123 µm.

Additional information