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Physical & Chemical properties

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:
2020
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

Constituent 1
Chemical structure
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
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.