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Physical & Chemical properties

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:
From 21/06/2016 to 21/06/2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Study performed in accordance with ISO 13320:2009 and CIPAC MT 187 test guidelines in compliance with GLP.
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Other quality assurance:
other: Audited by AQ unit in-house set out by QA SOP 010
Type of method:
Laser scattering/diffraction
Type of particle tested:
other:
Mass median aerodynamic diameter:
8.569 µm
Geometric standard deviation:
> 2.5 - < 2.531
Key result
Percentile:
D10
Mean:
1.964 µm
St. dev.:
0.8
Key result
Percentile:
D50
Mean:
8.097 µm
St. dev.:
0.5
Key result
Percentile:
D90
Mean:
17.929 µm
St. dev.:
1.1

Results

Standard visual observation

Sample observed to be a medium to fine white powder with lumps and clusters.

 

Observation at 100 x magnification

The particles appeared to be irregular shaped crystals. The smallest individual particle size was

approximately 3 μm and the largest individual size was approximately 80 μm.

 

Observation at 400 x magnification

The sample was observed to be made up of single crystalline particles with some agglomerations.

 

Full Test Results

 

Run 1

Run 2

Run 3

Run 4

Run 5

Average**

Volume weighted Mean

9.452

9.701

9.210

9.221

9.295

9.376

Median (d.50)

8.085

8.167

8.050

8.065

8.119

8.097

Mode (μm)

9.467

9.544

9.453

9.469

9.518

9.490

*MMAD

8.557

8.643

8.519

8.535

8.592

8.569

10 % of material is <

1.946

1.965

1.953

1.964

1.993

1.964

50 % of material is <

8.085

8.167

8.050

8.065

8.119

8.097

90 % of material is <

18.013

18.277

                

17.730

17.747

17.896

17.929

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.

62.12 % by volume of sample was seen to be<10.00 μm.

 

Standard Deviation results

Run No.

1

2

3

4

5

STDVP

%STDVP

D10

1.946

1.965

1.953

1.964

1.993

0.016

0.8

D50

8.085

8.167

8.050

8.065

8.119

0.042

0.5

D90

18.013

18.277

17.730

17.747

17.896

0.201

1.1

d15.78

3.195

3.229

3.202

3.216

3.248

0.019

0.6

GSD

2.531

2.529

2.514

2.508

2.500

0.012

0.5

MMAD

8.56

8.64

8.52

8.54

8.59

0.04

0.5

GSD = Geometric standard deviation of the lognormal particle size distribution

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.

Conclusions:
62.12 % by volume of sample was seen to be<10.00 μm.
Executive summary:

The objective of this study was to determine the particle size distribution of Lowinox® 22IB46, which was conducted in accordance with ISO 13320:2009 and CIPAC MT 187. The analysis was firstly conducted using a visual microscope to ascertain the particle characterisation of the test substance then more formally using Malvern Mastersizer 2000 Laser Diffraction Analyser.

 

The results of the laser diffraction test conducted to determine the particle size of the sample are summarised below. The analysis was conducted using the dry powder module (DPM).

Summary of Results

Particle Size Analysis using dry powder module (DPM)

Average (μm)

Volume weighted mean

9.376

Median (d.50)

8.097

Mode

9.490

MMAD (Mass Median Aerodynamic Diameter)

8.569

10 % of material is <

1.964

50 % of material is <

8.097

90 % of material is <

17.929

by volume of sample was seen to be < 10.00 μm

62.12 %

Description of key information

The objective of this study was to determine the particle size distribution of Lowinox® 22IB46, which was conducted in accordance with ISO 13320:2009 and CIPAC MT 187. The analysis was firstly conducted using a visual microscope to ascertain the particle characterisation of the test substance then more formally using Malvern Mastersizer 2000 Laser Diffraction Analyser.

 

The results of the laser diffraction test conducted to determine the particle size of the sample are summarised below. The analysis was conducted using the dry powder module (DPM).

Summary of Results

Particle Size Analysis using dry powder module (DPM)

Average (μm)

Volume weighted mean

9.376

Median (d.50)

8.097

Mode

9.490

MMAD (Mass Median Aerodynamic Diameter)

8.569

10 % of material is <

1.964

50 % of material is <

8.097

90 % of material is <

17.929

by volume of sample was seen to be < 10.00 μm

62.12 %

Additional information