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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:
13 August - 08 December 2015
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:
ISO 13320 (Particle size analysis - Laser diffraction methods)
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 stated in study reports): JNJ-4508530-AAA (T002707)
- Physical state: solid (powder)
- Appearance: white, beige powder
Specific details on test material used for the study:
- Name of test material (as cited in study report): JNJ-4508530-AAA (T002707)
- Physical state: solid
- Batch N°: I15BB0573
- Expiry date: 08 February 2017
- Storage condition: at room temperature

Results and discussion

Mass median aerodynamic diameter:
64.007 µm
Geometric standard deviation:
>= 1.663 - <= 1.723
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
28.317 µm
St. dev.:
0.05
Key result
Percentile:
D50
Mean:
54.886 µm
St. dev.:
0.178
Key result
Percentile:
D90
Mean:
98.439 µm
St. dev.:
0.904

Any other information on results incl. tables

Visual Microscope Analysis

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

(2) 100x magnification: particles appeared to be irregular shaped crystals (smallest +/- 3 µm and largest +/- 64 µm).

(3) 400x magnification: sample was observed to be made up of single crystalline particles and agglomerated 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 59.177 µm.

Average mode was determined to be 56.964 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 3 µm and 64 µm.
The particle size distribution of T002707 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 59.177 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 64.007 µm with a standard deviation (of the population) of 0.21 µm, whereas the average D10, D50 and the D90 were determined to be 28.317 µm, 54.886 µm and 98.439 µm, respectively.