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Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 August 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187 - Particle size analysis by laser diffraction
Deviations:
no
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of GLP Inspection: 25 January 2018 - 26 January 2018 Date of Issue: 10 September 2018
Type of method:
Laser scattering/diffraction
Type of particle tested:
agglomerate
Type of distribution:
volumetric distribution
Mass median aerodynamic diameter:
12.4 µm
Geometric standard deviation:
2.086
Key result
Percentile:
D50
Mean:
6.15 µm
St. dev.:
0.072
Percentile:
D10
Mean:
3.07 µm
St. dev.:
0.057
Percentile:
D90
Mean:
11.9 µm
St. dev.:
0.06

During the method development phase of the analysis trials were conducted using the small volume (wet) module (SVM) only. The SVM trials were conducted using water as the dispersant. The results of these trials indicated that the most appropriate test and material parameters to obtain the optimum measurements were:

Module: SVM

Dispersant: Water

Dispersion speed: 1700 rpm

Refractive index (sample): 0.000 n

Absorption: 0.000 AU

Analysis model: General purpose (normal)

Using the identified parameters, the particle size was analysed over the range 0.01 µm to 3500 µm. The results of the formal analysis are presented in Table 1. In addition, a graph of volume (%) versus Particle Diameter (µm) and full particle size distribution, is attached.

Table 1: Full Test Results

 

Run 1

Run 2

Run 3

Run 4

Run 5

Average

STDVP

% STD VP

VWM

8.26

9.28

10.1

10.9

11.4

9.99

N/A

N/A

Mode

6.38

6.30

6.24

6.19

6.15

6.25

N/A

N/A

d10

3.15

3.10

3.07

3.03

3.00

3.07

0.0572

1.86

d50 (median)

6.24

6.19

6.14

6.10

6.06

6.15

0.0717

1.17

d90

11.9

11.9

12.0

12.0

12.0

11.9

0.0602

0.504

MMAD

12.6

12.5

12.4

12.4

12.3

12.4

0.130

1.0

GSD

1.884

2.010

2.107

2.185

2.236

2.086

0.126

6.0

All particle size results are in µm

82.84% by volume of sample was seen to be < 10.00 µm

Definitions:

VWM : volume weighted mean

d10: 10% of the test item is less than this particle size

d50: 50% of the test item is less than this particle size

d90: 90% of the test item is less than this particle size

GSD: geometric standard deviation of the lognormal particle size distribition

MMAD: mass median aerodynamic diameter

Average: calculated from the entirety of the data captured in each run and not a simple arithmetic mean

STDVP: standard deviation of the population

%STDVP: percentage standard deviation of the population

The 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 is within the acceptable limits as per the ISO 13320-1 test standard

Conclusions:
The d10 was determined to be 3.07 µm, d50 was determined to be 6.15 µm, d90 was determined to be 11.9 µm. 82.84% of the sample is less than 10.0 µm. The results do not show any particles < 100 nm (0.1 µm).
Executive summary:

The results of the laser diffraction test conducted to determine the particle size of the test substance are summarised in the table below. The analysis was conducted using the small volume (wet) module (SVM) with water as the dispersant.

Particle size analysis using small volume (wet) module (SVM)

Average (µm)

Volume weighted mean

9.99

Mode

6.25

d10 (10% of material is <)

3.07

d50 (50% of material is <) median

6.15

d90 (90% of material is <)

1.19

MMAD (mass median aerodynamic diameter)

12.4

Volume of sample < 10.00 µm

82.84 %

The results do not show any particles < 100 nm (0.1 µm).

Description of key information

82.84% particles < 10 µm in diameter, d50: 6.15 µm; CIPAC MT 87; Livingston, I (2018)

Additional information

The results do not show any particles < 100 nm (0.1 µm).