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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 March 2017 - 17 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
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
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-7982559-AAA (T001329)
- Physical state: solid (powder)
- Appearance: Grey-brown powder
Specific details on test material used for the study:
- Lot/batch No.of test material: I14IB3639
- Expiration date of the lot/batch: 17 September 2020
- Purity: 97.9% (based on HPLC)
- Storage condition of test material: At room temperature

Results and discussion

Mass median aerodynamic diameter:
6.755 µm
Geometric standard deviation:
>= 2.259 - <= 2.274
Particle sizeopen allclose all
Percentile:
D10
Mean:
2.196 µm
St. dev.:
0.008
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:
6.192 µm
St. dev.:
0.042
Remarks on result:
other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
Percentile:
D90
Mean:
17.608 µm
St. dev.:
0.178
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 a fine, grey/brown powder with clusters.

(2) 100x magnification: particles appeared to be irregular shaped crystals (smallest +/- 3 µm and largest +/- 38 µm)

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

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 8.412 µm and the mode was 6.188 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 38 µm.
The particle size distribution of T001329 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 8.412 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 6.755 µm, whereas the average D10, D50 and the D90 were determined to be 2.196 µm, 6.192 µm and 17.608 µm, respectively.