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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:
24 August - 16 November 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: ISO 13320-1
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CTL SOP No. 417
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
1-((2-chlorophenyl)-N-methylcarbonimidoyl)cyclopentan-1-ol
EC Number:
641-894-8
Cas Number:
6740-87-0
Molecular formula:
C13H16ClNO
IUPAC Name:
1-((2-chlorophenyl)-N-methylcarbonimidoyl)cyclopentan-1-ol
Test material form:
solid
Specific details on test material used for the study:
- Lot/batch No.of test material: I17BB0589
- Expiration date of the lot/batch: 12 February 2018 (retest date)
- Analytical Purity: 99.50% (based on chromatographic purity)
- Storage condition of test material: In refrigerator (2-8°C) under argon

Results and discussion

Mass median aerodynamic diameter:
454.026 µm
Geometric standard deviation:
>= 2.24 - <= 2.37
Particle sizeopen allclose all
Percentile:
D10
Mean:
115.053 µm
St. dev.:
2.672
Remarks on result:
other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
Key result
Percentile:
D50
Mean:
402.883 µm
St. dev.:
4.997
Remarks on result:
other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
Percentile:
D90
Mean:
762.875 µm
St. dev.:
10.705
Remarks on result:
other: Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

Any other information on results incl. tables

Visual Microscope Analysis

(1) Standard visual observation: sample observed to be a medium and coarse white powder.

(2)  3.2 objective lens: particles appeared to be irregular shaped crystals (smallest +/- 19 µm and largest +/- 960 µm).

(3) 40 objective lens: sample was observed to be made up of single crystalline particles.

 

Laser Diffraction Particle Size Analysis

Using the identified parameters, the particle size was analysed over the range 0.2 μm to 2000 μm.

The average Volume weighted Mean was 426.456µm and the mode was 488.994µm. The Coefficient of Variation for d50 was <3%; d10 and d90 were <5%. Thus the repeatability of the characteristic particles in the size distribution was within the acceptable limits according to the ISO 13320-1 test standard.

Applicant's summary and conclusion

Conclusions:
Visual examination using 3.2 objective lens showed irregular shaped crystals between approximately 19 µm and 960 µm.
The particle size distribution of T003641 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 426.456 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 454.026 µm, whereas the average D10, D50 and the D90 were determined to be 2.672 µm, 4.997 µm and 10.705 µm, respectively.