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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
Guideline:
other: CTL SOP No. 417
Qualifier:
according to guideline
Guideline:
other: ISO 13320:2009
Qualifier:
according to guideline
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. QA statement)
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(2-{(E)-2-[(1E)-1-{(2E)-2-[1,1-dimethyl-3-(4-sulfobutyl)-1,3-dihydro-2H-benzo[e]indol-2-ylidene]ethylidene}-2-{methyl[(trifluoromethyl)sulfonyl]amino}-1H-inden-3-yl]vinyl}-1,1-dimethyl-1H-benzo[e]indolium-3-yl)butane-1-sulfonate compound with N,N-diethylethanamine (1:1)
EC Number:
940-889-0
Cas Number:
1770781-13-9
Molecular formula:
C51 H52 F3 N3 O8 S3 . C6 H15 N
IUPAC Name:
4-(2-{(E)-2-[(1E)-1-{(2E)-2-[1,1-dimethyl-3-(4-sulfobutyl)-1,3-dihydro-2H-benzo[e]indol-2-ylidene]ethylidene}-2-{methyl[(trifluoromethyl)sulfonyl]amino}-1H-inden-3-yl]vinyl}-1,1-dimethyl-1H-benzo[e]indolium-3-yl)butane-1-sulfonate compound with N,N-diethylethanamine (1:1)
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identification: CH03938
Appearance: Green-brown powder (determined by WIL Research Europe)
Batch: AD
Purity/Composition: 97.85% (HPLC)
KF content: 0.87% water
Test substance storage: At room temperature in well-sealed container
Stable under storage conditions until: Unknown
Chemical name (IUPAC), synonym or trade name: N,N-diethylethanamine; 4-[2-[(E)-2-[(3E)-3-[(2E)-2-[1,1- dimethyl-3-(4-sulfobutyl)benzo[e]indol-2-ylidene] ethylidene]- 2[methyl(trifluoromethylsulfonyl)amino]inden-1-yl]vinyl]-1,1- dimethyl-benzo[e]indol-3-ium-3-yl]butane-1-sulfonate
Molecular formula: C57H67F3N4O8S3
Molecular weight: 1089.37
Relative Density: 1.33 (Supplied by WIL Research Europe B.V.)

Results and discussion

Mass median aerodynamic diameter:
4.204 - 4.251 µm
Geometric standard deviation:
2.076 - 2.099
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:
1.431 µm
Percentile:
D50
Mean:
3.671 µm
Percentile:
D90
Mean:
9.237 µm

Any other information on results incl. tables

91.84 % by volume of < 1000 μm 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