Registration Dossier
Registration Dossier
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Particle size distribution (Granulometry)
Administrative data
Link to relevant study record(s)
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2020-12-14 to 2021-02-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Version / remarks:
- 2009
- Deviations:
- no
- GLP compliance:
- no
- 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:
- Batch No.: 472782
Purity: 99.8% - Mass median aerodynamic diameter:
- 50.7 µm
- Percentile:
- D10
- Mean:
- 9.9 µm
- Remarks on result:
- other: St. dev. not determined
- Percentile:
- D50
- Mean:
- 41.1 µm
- Remarks on result:
- other: St. dev. not determined
- Percentile:
- D90
- Mean:
- 115 µm
- Remarks on result:
- other: St. dev. not determined
- Conclusions:
- The D10, D50, D90 were determined to be 9.90, 41.1, 115 µm, respectively. MMAD (mass median aerodynamic diameter) was 50.7 µm.
- Executive summary:
The particle size analysis for test item was performed using medium volume (wet) module (MVM) based on ISO 13320:2009.
The D10, D50, D90 were determined to be 9.90, 41.1, 115 µm, respectively. MMAD (mass median aerodynamic diameter) was 50.7 µm.
Reference
Description of key information
The particle size analysis for test item was performed using medium volume (wet) module (MVM) based on ISO 13320:2009.
The D10, D50, D90 were determined to be 9.90, 41.1, 115 µm, respectively. MMAD (mass median aerodynamic diameter) was 50.7 µm.
Additional information
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