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Diss Factsheets

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:
1996-03-21 to 1996-07-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Remarks:
use of a Malvern Aerosizer and appropriate software

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
no guideline followed
Version / remarks:
The particle size was determined in triplicate using Malvern Aerosizer and appropriate software
Principles of method if other than guideline:
- Principle of test: Testing the particle size of the test substance
- Short description of test conditions: The particle size was obtained using an API Aerosizer Mach II and the appropriate software in triplicate, and the result determined from these tests.
- Parameters analysed / observed: Size of the tested particle.
GLP compliance:
yes
Type of method:
Laser scattering/diffraction
Type of particle tested:
agglomerate
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
421-300-1
EC Name:
-
Cas Number:
138564-59-7
Molecular formula:
C12H9N3O2S
IUPAC Name:
5-methyl-2-[(2-nitrophenyl)amino]thiophene-3-carbonitrile
Test material form:
solid: particulate/powder
Details on test material:
97.7%
Item code QA405K
Lilly lot no: 356MO1
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor and 356M01
- Expiration date of the lot/batch: 1997-01-04

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At ambient temperature in the dark.

Results and discussion

Mass median aerodynamic diameter:
ca. 3.28 µm
Particle size
Remarks on result:
other: Percentile, mean or std dev were not provided in the study report
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
3.28 µm
Remarks on result:
other: Distribution not provided on study report
No.:
#2
Size:
3.1 µm
Remarks on result:
other: Disrtibution not provided on study report
No.:
#3
Size:
3.46 µm
Remarks on result:
other: Disrtibution not provided on study report

Applicant's summary and conclusion

Conclusions:
The median particle size was determined to be 3.28 um.
Executive summary:

The test was not carried out in accordance with any guidelines, however it was carried out (under GLP) using a Malvern Aerosizer with the appropriate software.