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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:
11 - 14 January 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: European Commision, Directorate General XII-JRC, Science Research and Development-Joint Research Centre. "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document, ECB/TM/February 1996
Version / remarks:
"Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document, ECB/TM/February 1996
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-16169374-AAC (T002113)
- Physical state: solid (powder)
- Appearance: off-white powder
Specific details on test material used for the study:
- Batch n°: RT002113G3A231
- Analytical purity: 92.9%
- Expiration date: 08 April 2002
- Storage condition: at room temperature

Results and discussion

Particle sizeopen allclose all
Percentile:
other: D5
Mean:
0.7 µm
St. dev.:
0.048
Percentile:
D10
Mean:
1 µm
St. dev.:
0.091
Key result
Percentile:
D50
Mean:
6.8 µm
St. dev.:
0.399
Percentile:
D90
Mean:
23 µm
St. dev.:
0.934

Any other information on results incl. tables

Visual examination under the microscope (400x) showed small round colourless, crystalline structures after ultrasonification for 5 minutes.

Using the laser diffraction method the particle size of T002113 was found to range from approximately 0.5 µm to 60 µm. The results obtained during the measurements by laser scattering showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.

Particle Size Distribution:
µm              Mean %

< 0.3           ---
< 0.5           2.08
< 1.0           9.42
< 2.0           21.90
< 3.0           30.03
< 4.0           36.21
< 5.0           41.51
< 6.0           46.32
< 7.0           50.75
< 8.0           54.89
< 9.0           58.75
< 10.0          62.35
< 20.0          86.27
< 30.0          95.59
< 40.0          98.92
< 50.0          99.83
< 60.0          99.99
< 70.0          100.00
< 80.0          100.00
< 90.0          100.00
< 100.0         100.00
< 125.0         100.00
< 150.0         100.00


Applicant's summary and conclusion

Conclusions:
Visual examination (400x) showed small rounded colourless crystalline structures. The particle size distribution of T002113 was determined by the laser scattering method (following European Commission Guideline). Particle size was found to range from approximately 0.5 µm to 60 µm. The mass median diameter (MMD) was 6.8 µm, whereas the D10 and the D90 were determined to be 1.0 and 23.0 µm, respectively. The results of the study can be considered reliable without restriction.