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Physical & Chemical properties

Particle size distribution (Granulometry)

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Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 April 2015
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: In-house method
Principles of method if other than guideline:
Internal company analysis using laser scattering and water as the suspending medium.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
Lot number: 667A
Key result
Percentile:
D10
Mean:
5.434 µm
Remarks on result:
other: STDEV not reported
Key result
Percentile:
D50
Mean:
12.19 µm
Remarks on result:
other: STDEV not reported
Key result
Percentile:
D90
Mean:
22.98 µm
Remarks on result:
other: STDEV not reported
Conclusions:
Company data measured the particle size of the test item via laser scattering using water as the suspending medium. The mean particle size was reported to be 12.19 µm. There is a relatively narrow distribution in particles size.
Executive summary:

Company data measured the particle size of the test item via laser scattering using water as the suspending medium. The mean particle size was reported to be 12.19 µm. There is a relatively narrow distribution in particles size.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 September 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: In-house method
Principles of method if other than guideline:
Internal company analysis using laser scattering and water as the suspending medium.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
Lot number: 776A
Key result
Percentile:
D10
Mean:
3.143 µm
Remarks on result:
other: STDEV not reported
Key result
Percentile:
D50
Mean:
7.75 µm
Remarks on result:
other: STDEV not reported
Key result
Percentile:
D90
Mean:
16.62 µm
Remarks on result:
other: STDEV not reported
Conclusions:
Company data measured the particle size of the test item via laser scattering using water as the suspending medium. The mean particle size was reported to be 7.750 µm. There is a relatively narrow distribution in particles size.
Executive summary:

Company data measured the particle size of the test item via laser scattering using water as the suspending medium. The mean particle size was reported to be 7.750 µm. There is a relatively narrow distribution in particles size.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 March 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: In-house method
Principles of method if other than guideline:
Internal company analysis using laser scattering and water as the suspending medium.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
Lot number: 722A
Key result
Percentile:
D10
Mean:
2.367 µm
Remarks on result:
other: STDEV not reported
Key result
Percentile:
D50
Mean:
5.188 µm
Remarks on result:
other: STDEV not reported
Key result
Percentile:
D90
Mean:
9.859 µm
Remarks on result:
other: STDEV not reported
Conclusions:
Company data measured the particle size of the test item via laser scattering using water as the suspending medium. The mean particle size was reported to be 5.188 µm. There is a relatively narrow distribution in particles size.
Executive summary:

Company data measured the particle size of the test item via laser scattering using water as the suspending medium. The mean particle size was reported to be 5.188 µm. There is a relatively narrow distribution in particles size.

Description of key information

Three internal company studies measured the particle size of the test item via laser scattering using water as the suspending medium. Study MK-100K from 2017 measured reports the mean particle size to be 5.188 µm, study MK-200K from 2018 measured reports the mean particle size to be 7.750 µm and study MK-300K from 2015 measured reports the mean particle size to be 12.19 µm. The average particles sizes measured in the three studies are: D10 = 3.65 µm (SD 1.59), D50 = 8.38 µm (SD 3.54) and D90 = 16.49 µm (SD 6.56). There is a relatively narrow distribution in particles size.

Additional information