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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:
03 March - 26 April 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
Guideline:
other: ISO 13320:2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
METHYL (1R,2R,4S)-2-[HEX-5-EN-1-YL(METHYL)CARBAMOYL]-4-({7-METHOXY-8-METHYL-2-[4-(PROPAN-2-YL)-1,3-THIAZOL-2-YL]QUINOLIN-4-YL}OXY)CYCLOPENTANECARBOXYLATE
EC Number:
922-147-8
Cas Number:
1042695-87-3
Molecular formula:
C32H41N3O5S
IUPAC Name:
METHYL (1R,2R,4S)-2-[HEX-5-EN-1-YL(METHYL)CARBAMOYL]-4-({7-METHOXY-8-METHYL-2-[4-(PROPAN-2-YL)-1,3-THIAZOL-2-YL]QUINOLIN-4-YL}OXY)CYCLOPENTANECARBOXYLATE
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study reports): JNJ-39125593-AAA (T003019)
- Physical state: solid
- Appearance: white powder
Specific details on test material used for the study:
- Batch n°: M15FB2925
- Analytical purity: 99.5%
- Expiration date: 31 May 2017
- Storage condition: at room temperature protected from light

Results and discussion

Mass median aerodynamic diameter:
13.977 µm
Geometric standard deviation:
>= 3.307 - <= 3.361
Particle sizeopen allclose all
Percentile:
D10
Mean:
2.693 µm
St. dev.:
0.026
Percentile:
D50
Mean:
12.812 µm
St. dev.:
0.18
Percentile:
D90
Mean:
53.027 µm
St. dev.:
0.665

Any other information on results incl. tables

Visual Microscope Analysis

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

(2) 100x magnification: particles appeared to be irregular shapes (smallest +/- 3 µm and largest +/- 128 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 22.320 µm.

Average mode was determined to be 9.872 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 shapes between approximately 3 µm and 128 µm.
The particle size distribution of T003019 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 22.320 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 13.977 µm, whereas the average D10, D50 and the D90 were determined to be 2.693 µm, 12.812 µm and 53.027 µm, respectively.