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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to official guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: CTL SOP No. 417 Particle Size Analysis
Principles of method if other than guideline:
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:
mass based distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identification: V516690
Appearance: Brown to green powder (determined at WIL Research Europe)
Batch: V516690/AY
Purity/Composition: LC-MSpurity (Area% UV-VIS): 95.8% (Reference: PA064492)
Test item storage: At room temperature
Stable under storage conditions until 17 July 2016 (expiry date)
Molecular formula: C49H49ClN2O6S2
MW: 861.52

Results and discussion

Mass median aerodynamic diameter:
3.547 µm
Geometric standard deviation:
0.4
Particle sizeopen allclose all
Percentile:
D50
Mean:
3.123 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
1.257 µm
St. dev.:
0.4
Remarks on result:
other: St.Dev in %
Percentile:
D50
Mean:
3.123 µm
St. dev.:
0.9
Remarks on result:
other: St.Dev. in %
Percentile:
D90
Mean:
9.03 µm
St. dev.:
2.3
Remarks on result:
other: St.Dev. in %

Any other information on results incl. tables

  1. Standard visual observation: Sample observed to be a polydispersed green powder with lumps and clusters.

    Observation at 100 x magnification: The particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately 3 μm and the largest individual size was approximately 70 μm.

    Observation at 400 x magnification: The sample was observed to be made up of single crystalline particles and agglomerated particles.

Applicant's summary and conclusion

Conclusions:
The 10th, 50th and 90th percentile of particle diameter are 1.257, 3.123 and 9.030 µm, respectively. 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.