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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:
2003-11-17 to 2004-03-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of distribution:
mass based distribution
Specific details on test material used for the study:
- Analytical purity: 96%
- Lot/batch No.: 00410155
- Expiration date of the lot/batch: May 05, 2004
- Storage condition of test material: At room temperature at about 20°C.
Percentile:
other: D5
Mean:
1.9 µm
St. dev.:
0.128
Percentile:
D10
Mean:
3.7 µm
St. dev.:
0.36
Key result
Percentile:
D50
Mean:
19.3 µm
St. dev.:
1.228
Percentile:
D90
Mean:
46.4 µm
St. dev.:
3.443

Using the laser diffraction method the particle size of T002251 was found to range from approximately 0.3 µm to 90 µm. The results obtained during the measurements by laser scattering showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.

Visual examination under the microscope (400x) showed colourless squared crystalline structures.

Conclusions:
Visual examination (400x) showed colourless squared crystalline structures. The particle size distribution of T002251 was determined by the laser scattering method (following the European Commission Guideline). The particle size was found to range from approximately 0.3 µm to 90 µm. The mass median diameter (MMD) was 19.3 µm, whereas the D10 and the D90 were determined to be 3.7 and 46.4 µm, respectively. The results of the study can be considered reliable without restriction.

Description of key information

A GLP study according to the "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document of

the European Commission, Directorate General XII-JRC, Science Research and Development-Joint Research Centre (ECB/TM/February 1996) was carried out by Tognucci (K1, 2004) to determine the particle size of T002251.

Visual examination (400x) showed colourless squared crystalline structures. The particle size distribution, determined by the laser scattering method, was found to range from approximately 0.3 µm to 90 µm. The mass median diameter (MMD) was 19.3 µm, whereas the D10 and the D90 were determined to be 3.7 and 46.4 µm, respectively.

Additional information