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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 September 2016 - 28 November 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
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 test material (as cited in study report): JNJ-1580774-AAA (T000835)
- Physical state: solid powder
- Appearance: slight beige
Specific details on test material used for the study:
- Batch n°: I16BB1136
- Expiration date: 02 March 2017
- Purity: 99.3% (based on acid titration assay)
- Storage condition of test material: at room temperature

Results and discussion

Mass median aerodynamic diameter:
22.161 µm
Geometric standard deviation:
>= 2.041 - <= 2.132
Particle sizeopen allclose all
Percentile:
D10
Mean:
6.626 µm
St. dev.:
0.161
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:
18.094 µm
St. dev.:
0.128
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:
D90
Mean:
44.446 µm
St. dev.:
0.634
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 almost white powder with clusters and agglomerations.

(2) 100x magnification: particles appeared to be irregular shaped crystals (smallest +/- 3 µm and largest +/- 80 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 Kerosene. Therefore, Kerosene was used as the suspension fluid.

Laser Diffraction Particle Size Analysis

Using the identified parameters, the particle size was analysed over the range 0.02 μm to 2000 μm.

The average Volume weighted Mean was 22.346 µm and the mode was 18.064 µm. The Coefficient of Variation for d50 was <3%; d10 and d90 were <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 80 µm.
The particle size distribution of T000835 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 22.346 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 22.161 µm, whereas the average D10, D50 and the D90 were determined to be 6.626 µm, 18.094 µm and 44.446 µm, respectively.