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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:
key study
Study period:
12 August 2015 - 25 January 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: ISO 13320-2009
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): T001624
- Physical state: solid
- Appearance: white powder
- CAS: 132961-05-8
- Molecular formula: C23H28F2N4O2
- Molecular weight: 430.5 g/mol
Specific details on test material used for the study:
- Name of test material (as cited in study report): JNJ-7941726-AAA (T001624)
- Physical state: solid
- Batch N°: I14LC5175
- Expiry date: 11 December 2020
- Storage condition: at room temperature

Results and discussion

Mass median aerodynamic diameter:
46.572 µm
Geometric standard deviation:
>= 3.122 - <= 3.172
Particle sizeopen allclose all
Percentile:
D10
Mean:
9.247 µm
St. dev.:
0.087
Percentile:
D50
Mean:
40.847 µm
St. dev.:
0.592
Percentile:
D90
Mean:
163.441 µm
St. dev.:
0.769

Any other information on results incl. tables

Visual Microscope Analysis

(1) Standard visual observation: sample observed to be a medium to fine white powder with clusters.

(2) 100x magnification: particles appeared to be irregular shaped crystals (smallest +/- 6 µm and largest +/- 304 µm)

(3) 400x magnification: sample was observed to be made up of single crystalline particles.

Solubility and Dispersability Test

The sample proved to be insoluble and well dispersed in silicone oil. Therefore, silicone oil was used as the suspension fluid.

Laser Diffraction Particle Size Analysis

Average volume weighted mean was determined to be 65.318 µm.

Average mode was determined to be 42.037 µm.

The Coefficient of Variation (CV) for d50 wass <3%. For d10 and d90 it was <5%. Thus the repeatability of the characteristic particles in the size distribution was within the acceptable limits according to the ISO 13320-1 test standard.

Applicant's summary and conclusion

Conclusions:
Visual examination at 100x magnification showed irregular shaped crystals between approximately 6 µm and 304 µm.
The particle size distribution of T001624 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 65.318 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 46.572 µm with a standard deviation (of the population) of 0.67 µm, whereas the average D10, D50 and the D90 were determined to be 9.247 µm, 40.847 µm and 163.441 µm, respectively.