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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:
08 December 2010-10 December 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed according to ISO and CIPAC guidelines and according to GLP principles.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: ISO 13320:2009
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of distribution:
other: Particle Size Laser Diffraction Analysis

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SX-1
- Molecular formula: C31H24N4O4
- Molecular weight: 516.55
- Substance type: Pale yellow powder
- Physical state: solid
- Analytical purity: 99.7%
- Lot/batch No.: 008809
- Expiration date of the lot/batch: 02 November 2012
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Relative density: 1.37 (determined by NOTOX B.V.)

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Mean:
270.94 µm
Remarks on result:
other: average of 5 runs, result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean (% STDV MMAD=1.52)(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
Percentile:
D10
Mean:
< 40.151 µm
St. dev.:
0.12
Remarks on result:
other: St.dev. in µm, average of 5 runs
Percentile:
D50
Mean:
< 231.48 µm
St. dev.:
3.53
Remarks on result:
other: St.dev. in µm, average of 5 runs
Percentile:
D90
Mean:
< 663.619 µm
St. dev.:
22
Remarks on result:
other: St.dev. in µm, average of 5 runs

Any other information on results incl. tables

1.76% by volume of sample was seen to be < 10.00 µm.

Coefficient of variation (cv) for d50 is less than 3% (1.52%); cv for d10 and d90 are less than 5% (0.31% and 3.31%, respectively). Thus, repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.

Applicant's summary and conclusion

Conclusions:
Using the laser diffraction test ('wet' small volume dispersion system), the Mass Median Aerodynamic Diameter (MMAD) of SX-1 was determined to be 270.94 µm.

1.76% by volume of sample was seen to be < 10.00 µm.