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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:
21 - 24 May 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
ISO 13320:2009
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
Qualifier:
according to
Guideline:
other: Chilworth Technology Ltd SOP n°417
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of the test material (as cited in study reports): JNJ-63757109-AAA (T003690)
- Physical state: solid (powder)
- Appearance: white to slightly yellow power
Specific details on test material used for the study:
- Batch n°: I17BD0751
- Analytical purity: 99.9 % (based on titration assay)
- Expiration date: 24 February 2019
- Storage condition: at room temperature

Results and discussion

Mass median aerodynamic diameter:
83.4 µm
Geometric standard deviation:
>= 2.216 - <= 2.227
Particle sizeopen allclose all
Percentile:
D10
Mean:
23.6 µm
St. dev.:
0.444
Remarks on result:
other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
Key result
Percentile:
D50
Mean:
69.3 µm
St. dev.:
1.04
Remarks on result:
other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
Percentile:
D90
Mean:
178 µm
St. dev.:
2.41
Remarks on result:
other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

Any other information on results incl. tables

Visual Microscope Analysis

(1) Standard visual observation: sample observed to be a fine and medium, slightly yellow powder with clusters.

(2) Observation using 3.2 objective lens: particles appeared to be irregular shaped crystals (smallest +/- 6 μm and largest +/- 256 μm)

(3) Observation using 40 objective lens: sample was observed to be made up of single crystalline particles.

Laser Diffraction Particle Size Analysis

Using the identified parameters, the particle size was analysed over the range 0.01 μm to 3500 μm.

The average Volume weighted Mean was 86.6 µm and the mode was 70.1 µm. The coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distributions are within the acceptable limits as per the ISO 13320 -1 test standard.

Applicant's summary and conclusion

Conclusions:
Visual examination with 3.2 objective lens showed irregular shaped crystals between approximately 6 μm and 256 μm. The particle size distribution of T003690 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 86.6 μm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 83.4 μm, whereas the average D10, D50 and the D90 were determined to be 23.6 μm, 69.3 μm and 178 μm, respectively.