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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Determination of the particle size distribution by laser diffraction
GLP compliance:
not specified
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
Test data for two product lots of Luvotix PAB:
- Lot. 500181201
- Lot. 500190201
Percentile:
D10
Mean:
1.02 µm
Remarks on result:
other: St. dev. not calculated
Remarks:
Lot. 500181201, Experiment 1
Percentile:
D50
Mean:
4.94 µm
Remarks on result:
other: St. dev. not calculated
Remarks:
Lot. 500181201, Experiment 1
Percentile:
D99
Mean:
19.91 µm
Remarks on result:
other: St. dev. not calculated
Remarks:
Lot. 500181201, Experiment 1
Percentile:
D10
Mean:
0.98 µm
Remarks on result:
other: St. dev. not calculated
Remarks:
Lot. 500181201, Experiment 2
Percentile:
D50
Mean:
4.73 µm
Remarks on result:
other: St. dev. not calculated
Remarks:
Lot. 500181201, Experiment 2
Percentile:
D99
Mean:
19.48 µm
Remarks on result:
other: St. dev. not calculated
Remarks:
Lot. 500181201, Experiment 2
Percentile:
D10
Mean:
0.93 µm
Remarks on result:
other: St. dev. not calculated
Remarks:
Lot. 500190201, Experiment 1
Percentile:
D50
Mean:
4.36 µm
Remarks on result:
other: St. dev. not calculated
Remarks:
Lot. 500190201, Experiment 1
Percentile:
D99
Mean:
19.59 µm
Remarks on result:
other: St. dev. not calculated
Remarks:
Lot. 500190201, Experiment 1
Percentile:
D10
Mean:
0.96 µm
Remarks on result:
other: St. dev. not calculated
Remarks:
Lot. 500190201, Experiment 2
Percentile:
D50
Mean:
4.42 µm
Remarks on result:
other: St. dev. not calculated
Remarks:
Lot. 500190201, Experiment 2
Percentile:
D99
Mean:
19.86 µm
Remarks on result:
other: St. dev. not calculated
Remarks:
Lot. 500190201, Experiment 2

Surface mean diameter:

  • Lot. 500181201, Experiment 1: 2.71 µm
  • Lot. 500181201, Experiment 2: 2.61 µm
  • Lot. 500190201, Experiment 1: 2.47 µm
  • Lot. 500190201, Experiment 2: 2.51 µm

Volume mean diameter:

  • Lot. 500181201, Experiment 1: 5.76 µm
  • Lot. 500181201, Experiment 2: 5.63 µm
  • Lot. 500190201, Experiment 1: 5.45 µm
  • Lot. 500190201, Experiment 2: 5.51 µm
Conclusions:
The surface mean diameter of the test material is determined between 2.47 - 2.71 µm (arithmetic mean: 2.58 µm). The volume mean diameter of the test material is determined between 5.45 - 5.76 µm (arithmetic mean: 5.59 µm). The D50 ranges between 4.36 - 4.94 µm (arithmetic mean: 4.61 µm).
Executive summary:

The particle size distribution of the test material was determined using laser diffraction for two product lots (two experimental runs per sample). The surface mean diameter of the test material is determined between 2.47 - 2.71 µm (arithmetic mean: 2.58 µm). The volume mean diameter of the test material is determined between 5.45 - 5.76 µm (arithmetic mean: 5.59 µm). The D50 ranges between 4.36 - 4.94 µm (arithmetic mean: 4.61 µm).

Description of key information

The particle size distribution of the test material was determined using laser diffraction using two product lots (two experimental runs per sample). The surface mean diameter of the test material is determined between 2.47 - 2.71 µm (arithmetic mean: 2.58 µm). The volume mean diameter of the test material is determined between 5.45 - 5.76 µm (arithmetic mean: 5.59 µm). The D50 ranges between 4.36 - 4.94 µm (arithmetic mean: 4.61 µm).

Additional information