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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:
24 Jan 20118 - 29 Jan 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 guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
GLP compliance:
yes
Other quality assurance:
other: ISO 13320:2009 “Particle Size Analysis – Laser Diffraction Methods
Type of method:
Laser scattering/diffraction
Type of particle tested:
agglomerate
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dihydropurin-6-one;sodium
Cas Number:
45738-97-4
Molecular formula:
C5H3N4NaO
IUPAC Name:
3,7-dihydropurin-6-one;sodium
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: White powder
- Purity / Composition: 98%
- Test item storage: Room temperature

Results and discussion

Mass median aerodynamic diameter:
ca. 3.717 µm
Geometric standard deviation:
> 1.964 - < 1.991
Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
ca. 1.177 µm
St. dev.:
0.012
Key result
Percentile:
D50
Mean:
ca. 2.748 µm
St. dev.:
0.045
Key result
Percentile:
D90
Mean:
ca. 6.801 µm
St. dev.:
0.108

Any other information on results incl. tables

Table 8:1 : Full Test Results

 Run No.

RUN 1

RUN 2

RUN 3

RUN 4

RUN 5

Average**

Volume weighted mean

3.556

3.512

3.497

3.437

3.418

3.484

Median

2.808

2.787

2.749

2.702

2.694

2.748

Mode

2.708

2.695

2.625

2.568

2.569

2.631

MMAD *

3.799

3.771

3.719

3.655

3.645

3.717

d10 - 10 % of material is <

1.193

1.189

1.175

1.166

1.165

1.177

d50 - 50 % of material is <

2.808

2.787

2.749

2.702

2.694

2.748

d90 - 90 % of material is <

6.953

6.846

6.844

6.706

6.651

6.801

 

All results are in µm

* Mass median aerodynamic diameter

** Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.

97.17 % by volume of sample was seen to be < 10.00 µm

 

Table 8:2: Standard Deviation results

Run No.

1

2

3

4

5

STDVP

% STDVP

d10 - 10 % of material is <

1.193

1.189

1.175

1.166

1.165

0.012

1

d50 - 50 % of material is <

2.808

2.787

2.749

2.702

2.694

0.045

1.6

d90 - 90 % of material is <

6.953

6.846

6.844

6.706

6.651

0.108

1.6

d15.78 - 15.78 % of material is <

1.41

1.404

1.387

1.374

1.372

0.015

1.1

GSD

1.991

1.985

1.982

1.967

1.964

0.011

0.5

MMAD

3.799

3.771

3.719

3.655

3.645

0.061

1.6

 

GSD = Geometric standard deviation of the lognormal particle size distribution (calculated from d50/d15.78) STDVP = standard deviation of the population

% STDVP = percentage standard deviation of the population

 

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

Conclusions:
The particle size was analyzed over the range 0.02 µm to 2000 µm using a DPM Module. The average result is calculated from the entirety of data captured in each of the five runs. The averages are: d10 - 10 % of material is <1.177, d50 - 50 % of material is <2.748, and d90 - 90 % of material is <6.801.

Executive summary:

The particle size was analyzed over the range 0.02 µm to 2000 µm using a DPM Module. The average result is calculated from the entirety of data captured in each of the five runs. The averages are: d10 - 10 % of material is <1.177, d50 - 50 % of material is <2.748, and d90 - 90 % of material is <6.801.