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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:
11 January 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
2009
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 187
Deviations:
no
Qualifier:
equivalent or similar 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 (incl. QA statement)
Type of method:
Laser scattering/diffraction
Specific details on test material used for the study:
The analysis was conducted using the dry powder module.
Mass median aerodynamic diameter:
645.987 µm
Geometric standard deviation:
0.04
Key result
Percentile:
D50
Mean:
645.987 µm
St. dev.:
12.16
Key result
Percentile:
D10
Mean:
160.487 µm
St. dev.:
3.28
Key result
Percentile:
D90
Mean:
1 353.261 µm
St. dev.:
10.07
No.:
#1
Size:
< 10 µm
Distribution:
0.42 %

OPTICAL MICROSCOPE ANALYSIS

- Standard visual observation: The sample was observed to be a free-flowing, coarse, gritty powder with clusters, some of the clusters were greater than 2000 μm.

- Observation at 100 x magnification: The particles appeared to be irregular shaped crystals. The smallest individual particle size was approximately 6.4 μm and the largest individual size was approximately 1216 μm.

- Observation at 400 x magnification: The sample was observed to be made up of both single and agglomerated crystalline particles.

 

MANUAL SIEVE ANALYSIS

- Result : 94.18 % by weight < 2000 μm

Table 1: Manual Sieve Analysis Results

Sieve Size (µm)

Sieve Weight (g)

Sieve + Powder Weight (g)

Powder Weight (g)

% By Weight

> 2000

326

338.3

12.3

5.82

< 2000

246.1

445.3

199.2

94.18

TOTALS

211.5

100

 

LASER DIFFRACTION PARTICLE SIZE ANALYSIS

Table 2: Laser Diffraction Analysis Results

 

RUN 1

RUN 2

RUN 3

RUN 4

RUN 5

*Average

Volume Weighted Mean

715.117

712.929

699.033

717.006

696.276

708.272

Median (d.50)

656.425

653.006

634.008

657.846

628.762

645.987

Mode (µm)

855.405

856.641

833.273

880.259

839.512

853.347

10% of material is <

162.946

165.309

159.867

158.537

155.965

160.487

50% of material is <

656.425

653.006

634.008

657.846

628.762

645.987

90% of material is <

1356.892

1356.840

1340.168

1367.801

1343.341

1353.261

All results are in μm

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

0.42% by volume of sample was seen to be < 10.00 μm.

Table 3: Standard Deviation Results

Run No.

1

2

3

4

5

ST DVP

% STDV

d10

162.946

165.309

159.867

158.537

155.965

3.28

2.05

d50

656.425

653.006

634.008

657.846

628.762

12.16

1.88

d90

1356.892

1356.840

1340.168

1367.801

1343.341

10.07

0.74

d15.78

243.700

245.440

236.370

237.440

232.460

4.81

2.01

*GSD

2.694

2.661

2.682

2.771

2.705

0.04

1.37

*GSD = Geometric standard deviation

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 BS ISO 13320-1 test standard.

Conclusions:
Under the conditions of this study manual sieve analysis indicated that 94.18% by weight of the sample had a particle size of < 2000 μm. A subsequent laser diffraction analysis on the < 2000 μm sample produced the following results: Volume weighted mean = 708.272 µm, Median (d.50) = 645.987 µm, Mode = 853.347 µm, 10% of material was < 160.487 µm, 50% of material was < 645.987 µm and 90% of material was < 1353.261 µm. 0.42% by volume of the test material sample was seen to be < 10.00 μm
Executive summary:

The particle size distribution of the test material was investigated in accordance with the standardised guidelines ISO 13320:2009 and CIPAC MT 187, taking into consideration OECD guideline 110. The testing was performed under GLP conditions.

The analysis was conducted using the dry powder module.

Under the conditions of this study manual sieve analysis indicated that 94.18% by weight of the sample had a particle size of < 2000 μm. A subsequent laser diffraction analysis on the < 2000 μm sample produced the following results: Volume weighted mean = 708.272 µm, Median (d.50) = 645.987 µm, Mode = 853.347 µm, 10% of material was < 160.487 µm, 50% of material was < 645.987 µm and 90% of material was < 1353.261 µm. 0.42% by volume of the test material sample was seen to be < 10.00 μm.

Description of key information

Under the conditions of the study manual sieve analysis indicated that 94.18% by weight of the sample had a particle size of < 2000 μm. A subsequent laser diffraction analysis on the < 2000 μm sample produced the following results: Volume weighted mean = 708.272 µm, Median (d.50) = 645.987 µm, Mode = 853.347 µm, 10 % of material was < 160.487 µm, 50 % of material was < 645.987 µm and 90 % of material was < 1353.261 µm. 0.42% by volume of the test material sample was seen to be < 10.00 μm

Additional information

The particle size distribution of the test material was investigated in accordance with the standardised guidelines ISO 13320:2009 and CIPAC MT 187, taking into consideration OECD guideline 110. The testing was performed under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The analysis was conducted using the dry powder module.

Under the conditions of the study manual sieve analysis indicated that 94.18 % by weight of the sample had a particle size of < 2000 μm. A subsequent laser diffraction analysis on the < 2000 μm sample produced the following results: Volume weighted mean = 708.272 µm, Median (d.50) = 645.987 µm, Mode = 853.347 µm, 10% of material is < 160.487 µm, 50% of material is < 645.987 µm and 90% of material is < 1353.261 µm. 0.42% by volume of the test material sample was seen to be < 10.00 μm.