Registration Dossier

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:
07 Nov 2017 to 08 Nov 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Qualifier:
according to
Guideline:
other:
Version / remarks:
CIPAC MT 187
Principles of method if other than guideline:
The analysis was conducted initially using a visual microscope and was then undertaken more formally using a Laser Diffraction Particle Size Analyser. The sample was observed under 3 conditions: Direct observation, under a microscope with 32 x magnification, under a microscope with 400 x magnification. The physical characteristics of the material were recorded, noting such items as shape and size distribution. Following this the Malvern Mastersizer 2000 Laser Diffraction Analyser was used. Five runs of the method were conducted to ensure repeatability of results.
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Lot number: 2000850599
Analysis date: 19 August 2016
Specific details on test material used for the study:
Lot number: 2000850599

Results and discussion

Mass median aerodynamic diameter:
420.202 µm
Geometric standard deviation:
2.63
Remarks on result:
other: 0.0 % by volume of sample was seen to be < 10.00 µm.
Particle sizeopen allclose all
Percentile:
D10
Mean:
< 109.523 µm
St. dev.:
0.759
Remarks on result:
other: % STDVP 0.7
Percentile:
D50
Mean:
< 394.563 µm
St. dev.:
3.746
Remarks on result:
other: % STDVP 1.0
Percentile:
D90
Mean:
< 900.816 µm
St. dev.:
22.11
Remarks on result:
other: % STDVP 2.5

Any other information on results incl. tables

Standard visual observation: Sample observed to be a medium to coarse, off-white crystalline powder with some clusters.

Observation at 32 x magnification: The particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately 29 µm and the largest individual size was approximately 768 µm.

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

Applicant's summary and conclusion

Conclusions:
The mass median aerodynamic diameter was determined to be 420.202 um.