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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:
23 May - 25 May 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 13320-1
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 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 reports): JNJ-117676-AAA (T000263)
- Physical state: solid (powder)
- Appearance: White, slight beige amorphous, crystalline, micropowder
Specific details on test material used for the study:
- Batch n°: I15BB0491
- Analytical purity: 99.8% (base titration)
- Expiration date: 04 February 2021
- Storage condition: at room temperature

Results and discussion

Mass median aerodynamic diameter:
327.192 µm
Geometric standard deviation:
>= 2.915 - <= 2.943
Particle sizeopen allclose all
Percentile:
D10
Mean:
65.742 µm
St. dev.:
0.409
Percentile:
D50
Mean:
286.966 µm
St. dev.:
2.427
Percentile:
D90
Mean:
555.286 µm
St. dev.:
1.465

Any other information on results incl. tables

Visual Microscope Analysis

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

(2) 100x magnification: particles appeared to be irregular shapes (smallest +/- 3 µm and largest +/- 496 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 kerosene, silicone oil and sunflower oil. However, kerosene was selected for the suspension fluid as it was less viscous than the other samples.

Laser Diffraction Particle Size Analysis

Average volume weighted mean was determined to be 300.246 µm.

Average mode was determined to be 393.178 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 shapes between approximately 3 µm and 496 µm.
The particle size distribution of T000263 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 300.246 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 327.192 µm, whereas the average D10, D50 and the D90 were determined to be 65.742 µm, 286.966 µm and 555.286 µm, respectively.