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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:
2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test performed according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: CTL SOP No. 417
Qualifier:
according to
Guideline:
other: ISO 13320:2009
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Principles of method if other than guideline:
To characterise the particle size distribution of the powder. The analysis is conducted initially using a visual microscope and is then undertaken more formally using a Laser Diffraction Particle Size Analyser. The benefit of this procedure is that it allows the operator to obtain a better understanding of the particle characterisation of the material. This includes, but is not limited to, sample clusters and agglomerations which may provide false values in the formal particle size analysis. In these situations, where the operator can assess how easily these clusters or agglomerations are dispersed, ultrasonics may be employed. Owing to the extremely small quantities of material used in this analysis it should be noted that discrepancies can arise between the lower and upper limits of the particle size and the actual value obtained in the formal particle size analysis.
GLP compliance:
yes (incl. certificate)
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identification: V173520
Appearance: White powder (determined by WIL Research Europe)
Batch number: AN
Purity / composition: Not indicated
Test substance storage: At room temperature
Stable under storage conditions until: 20 April 2017 (expiry date)
Chemical name (IUPAC), synonym or trade name: 1,1,2,2-tetramethyl-1H-Benz(e)indolium 4-methylbenzene sulfonate
CAS number: 141914-99-0
Relative density: 1.28 (determined by WIL Research Europe)
Molecular formula: C23H25NO3S
Molecular weight: 395.53

Results and discussion

Mass median aerodynamic diameter:
43.236 - 44.813 µm
Geometric standard deviation:
3.672 - 3.746
Particle sizeopen allclose all
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
7.217 µm
Percentile:
D50
Mean:
38.573 µm
Percentile:
D90
Mean:
120.404 µm

Any other information on results incl. tables

14.90 % by volume of sample was seen to be <10.00 μm

Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. 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