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Diss Factsheets

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:
18 April 2017 - 19 April 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: Chilworth Technology Ltd SOP n°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:
3-(2-hydroxyethyl)-1H,3H-quinazoline-2,4-dione
EC Number:
214-897-3
EC Name:
3-(2-hydroxyethyl)-1H,3H-quinazoline-2,4-dione
Cas Number:
1207-75-6
Molecular formula:
C10H10N2O3
IUPAC Name:
3-(2-hydroxyethyl)-1,2,3,4-tetrahydroquinazoline-2,4-dione
Test material form:
solid
Specific details on test material used for the study:
- Batch n°: I16JB3859
- Expiration date: 15 October 2018
- Purity: 99.4% (based on acid titration)
- Storage condition of test material: at room temperature

Results and discussion

Mass median aerodynamic diameter:
109.451 µm
Geometric standard deviation:
>= 3.432 - <= 3.493
Particle sizeopen allclose all
Percentile:
D10
Mean:
18.066 µm
St. dev.:
0.167
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:
89.666 µm
St. dev.:
1.213
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:
300.004 µm
St. dev.:
2.807
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 medium to fine white powder with clusters.

(2) Observation using 3.2 objective lens: particles appeared to be irregular shaped crystals (smallest +/- 6 µm and largest +/- 304 µm)

(3) Observation using 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 0.02 μm to 2000 μm.

The average Volume weighted Mean was 128.117 µm and the mode was 160.021 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:
Visual examination using 3.2 objective lens showed irregular shaped crystals between approximately 6 µm and 304 µm.
The particle size distribution of T001200 determined by the laser diffraction method led to the conclusion that the average volume weighted mean based on 5 runs was 128.117 µm and the Mass Median Aerodynamic Diameter (MMAD) based on 5 runs was 109.451 µm, whereas the average D10, D50 and the D90 were determined to be 18.066 µm, 89.666 µm and 300.004 µm, respectively.