Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- Laser scattering/diffraction
Test material
- Reference substance name:
- (2S)-1,1-bis(4-fluorophenyl)propan-2-yl L-alaninate hydrochloride
- Cas Number:
- 2171323-89-8
- Molecular formula:
- C18H20CIF2NO2
- IUPAC Name:
- (2S)-1,1-bis(4-fluorophenyl)propan-2-yl L-alaninate hydrochloride
Constituent 1
- Specific details on test material used for the study:
- Substance name: BFPA HCl salt
Lot #: SS17000577 (TSN400390)
Purity: 100%
Results and discussion
- Mass median aerodynamic diameter:
- 280 µm
Particle sizeopen allclose all
- Key result
- Percentile:
- other: d(0.1)
- Mean:
- 58 µm
- Remarks on result:
- other: diameter where 90% of the distribution is above and 10% is below
- Key result
- Percentile:
- other: d(0.5)
- Mean:
- 280 µm
- Remarks on result:
- other: diameter where 50% of the distribution is above and 50% is below. The is referred to as the Mass Median Diameter (MMD)
- Key result
- Percentile:
- other: d(0.9)
- Mean:
- 570 µm
- Remarks on result:
- other: diameter where 10% of the distribution is above and 90% is below
Applicant's summary and conclusion
- Conclusions:
- The test substance was determined to have d(0.1), d(0.5) and d(0.9) values of 58, 280 and 570 μm, respectively.
- Executive summary:
A study was conducted to determine the particle size distribution of the test substance.
The particle size distribution was assessed using a technique based on laser diffraction in accordance with CIPAC MT 187.
The test substance was determined to have d(0.1), d(0.5) and d(0.9) values of 58, 280 and 570 μm, respectively.
d(0.1) is the diameter where 90% of the distribution is above and 10% is below.
d(0.5) is the diameter where 50% of the distribution is above and 50% is below. The is referred to as the Mass Median Diameter (MMD).
d(0.9) is the diameter where 10% of the distribution is above and 90% is below.
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