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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:
10 December 2015 - 25 February 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 report): JNJ-38940642-AAA (T003010)
- Physical state: solid
- Appearance: white powder

Results and discussion

Mass median aerodynamic diameter:
7.769 µm
Geometric standard deviation:
>= 2.556 - <= 2.572
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
1.599 µm
St. dev.:
0.02
Key result
Percentile:
D50
Mean:
6.737 µm
St. dev.:
0.07
Key result
Percentile:
D90
Mean:
18.617 µm
St. dev.:
0.47

Any other information on results incl. tables

Visual Microscope Analysis

(1) Standard visual observation: sample observed to be a polydispersed white powder with clusters.

(2) 100x magnification: particles appeared to be needles / fibre crystals (smallest +/- 3 µm and largest +/- 70 µm)

(3) 400x magnification: sample was observed to be made up of crystalline particles.

Laser Diffraction Particle Size Analysis

Average volume weighted mean was determined to be 9.409 µm.

Average mode was determined to be 7.148 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 needles / fibre crystals between approximately 3 µm and 70 µm.
The particle size distribution of T003010 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 9.409 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 7.769 µm with a standard deviation (of the population) of 0.08 µm, whereas the average D10, D50 and the D90 were determined to be 1.599 µm, 6.737 µm and 18.617 µm, respectively.