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:
15 May 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
ISO 13320:2009
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 187
Deviations:
no
Qualifier:
according to
Guideline:
other: Chilworth Technology Ltd SOP n°417
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Physical state: powder/solid
- Appearance: white powder
Specific details on test material used for the study:
- Batch n°: 397451
- Expiration date: 07 July 2018
- Purity: 99.86 %
- Storage condition of test material: In refrigerator (2-8°C)

Results and discussion

Mass median aerodynamic diameter:
54.9 µm
Geometric standard deviation:
>= 2.536 - <= 2.562
Particle sizeopen allclose all
Percentile:
D10
Mean:
11.5 µm
St. dev.:
0.095
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:
45.6 µm
St. dev.:
0.454
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:
111 µm
St. dev.:
1.89
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 polydispersed white powder with lumps and clusters.

(2) 3.2 objective lens: particles appeared to be irregular shaped crystals (smallest +/- 3 µm and largest +/- 144 µm).

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

Solubility and Dispersability Test

The sample proved to be insoluble and well dispersed in water. Therefore, water was used as the disperant.

Laser Diffraction Particle Size Analysis

Using the identified parameters, the particle size was analysed over the range 0.01 µm to 3500 µm.

The average Volume weighted Mean was 54.8 µm and the mode was 57.0 µm. 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:
Observation using 3.2 objective lens showed irregular shaped crystals between approximately 3 µm and 144 µm.
The particle size distribution of PDO determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 54.8 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 54.9 µm, whereas the average D10, D50 and the D90 were determined to be 11.5 µm, 45.6 µm and 111 µm, respectively.