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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:
8 June - 13 June 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:
2017

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-17298957-AAA (T001592)
- Physical state: solid (powder)
- Appearance: White powder
Specific details on test material used for the study:
- Batch n°:I15HB2929
- Expiration date: 14 August 2017
- Purity:100% (based on base titration assay)
- Storage condition of test material:at room temperature

Results and discussion

Mass median aerodynamic diameter:
29.736 µm
Geometric standard deviation:
0.036
Particle sizeopen allclose all
Percentile:
D10
Mean:
7.198 µm
St. dev.:
0.09
Percentile:
D50
Mean:
26.597 µm
St. dev.:
0.169
Percentile:
D90
Mean:
80.779 µm
St. dev.:
0.384

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 lumps and clusters.

(2) 100x magnification: particles appeared to be crystalline with needles and fibres (smallest +/- 3 µm and largest +/- 144 µm).

(3) 400x magnification: sample was observed to be made up of single crystalline particles. Some aggregations were also present.

Solubility and Dispersability Test

The sample proved to be insoluble and well dispersed in kerosene and silicone oil. During the method development kerosene was found to be unsuitable due to the obscuration data obtained. Therefore, silicone oil was used as the suspension fluid.

Laser Diffraction Particle Size Analysis

Average volume weighted mean was determined to be 39.043 µm.

Average mode was determined to be 27.875 µm.

The Coefficient of Variation (CV) for d50 was <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 crystalline particles with needles and fibres between approximately 3 µm and 144 µm.
The particle size distribution of T001592 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 39.043 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 29.736 µm with a standard deviation (of the population) of 0.19 µm, whereas the average D10, D50 and the D90 were determined to be 7.198 µm, 26.597 µm and 80.779 µm, respectively.