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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:
24 July 2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No guideline followed and only 1 run was conducted. Still considered reliable as the study is performed with a commonly used apparatus and as the results are well described.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The analysis is conducted using Laser Diffraction Particle Size Analysis.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
509.639 µm
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
150.468 µm
Remarks on result:
other: (based on 1 run)
Percentile:
D50
Mean:
387.471 µm
Remarks on result:
other: (based on 1 run)
Percentile:
D90
Mean:
945.203 µm
Remarks on result:
other: (based on 1 run)
Size:
< 10 µm
Distribution:
0.34 %
Remarks on result:
other: (based on 1 run)

Span: 2.051

Conclusions:
The particle size distribution of a sample of the substance was determined by laser diffraction analysis-dry powder module; 0.34% is < 10 µm; < 10% is < 150 µm; 50% is < 387 µm and 90% is < 945 µm. The MMAD was determined to be 510 µm.
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 July 2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No guideline followed and only 1 run was conducted. Still considered reliable as the study is performed with a commonly used apparatus and as the results are well described.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The analysis is conducted using Laser Diffraction Particle Size Analysis.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
637.354 µm
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
187.384 µm
Remarks on result:
other: (based on 1 run)
Percentile:
D50
Mean:
484.571 µm
Remarks on result:
other: (based on 1 run)
Percentile:
D90
Mean:
1 032.097 µm
Remarks on result:
other: (based on 1 run)
Size:
< 10 µm
Distribution:
0 %
Remarks on result:
other: (based on 1 run)

Span: 1.743

Conclusions:
The particle size distribution of a sample of the substance was determined by laser diffraction analysis-dry powder module; 0% is < 10 µm; 10% is < 187 µm; 50% is < 485 µm and 90% is < 1032 µm. The MMAD was determined to be 637 µm.
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 July 2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No guideline followed and only 1 run was conducted. Still considered reliable as the study is performed with a commonly used apparatus and as the results are well described.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The analysis is conducted using Laser Diffraction Particle Size Analysis.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
533.69 µm
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
142.674 µm
Remarks on result:
other: (based on 1 run)
Percentile:
D50
Mean:
405.757 µm
Remarks on result:
other: (based on 1 run)
Percentile:
D90
Mean:
868.098 µm
Remarks on result:
other: (based on 1 run)
Size:
< 10 µm
Distribution:
0.3 %
Remarks on result:
other: (based on 1 run)

Span: 1.788

Conclusions:
The particle size distribution of a sample of the substance was determined by laser diffraction analysis-dry powder module; 0.3% is < 10 µm; 10% is < 143 µm; 50% is < 406 µm and 90% is < 868 µm. The MMAD was determined to be 534 µm.
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 July 2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No guideline followed and only 1 run was conducted. Still considered reliable as the study is performed with a commonly used apparatus and as the results are well described.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The analysis is conducted using Laser Diffraction Particle Size Analysis.
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
629.175 µm
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
177.485 µm
Remarks on result:
other: (based on 1 run)
Percentile:
D50
Mean:
478.353 µm
Remarks on result:
other: (based on 1 run)
Percentile:
D90
Mean:
998.676 µm
Remarks on result:
other: (based on 1 run)
Size:
< 10 µm
Distribution:
0.13 %
Remarks on result:
other: (based on 1 run)

Span: 1.717

Conclusions:
The particle size distribution of a sample of the substance was determined by laser diffraction analysis-dry powder module; 0.13% is µm < 10 µm; 10% is < 177 µm; 50% is < 478 µm and 90% is < 999 µm. The MMAD was determined to be 629 µm.

Description of key information

The MMAD was determined to be 577 µm. D10= 164.5 µm; D50= 439 µm and D90= 961 µm; < 0.2% by volume is < 10 µm.

Additional information

Average of 4 analyses, on 4 different batches, determined by Laser diffraction analysis-dry powder module.