SUMILIZER GP

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31-Mar to 10-Apr-2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

European Commission, Document ECB/TM/February 1996: "Particle Size Distribution, Fibre Length and Diameter Distribution" Guidance Document using the laser diffraction method.

GLP compliance:

yes (incl. QA statement)

Remarks:

The Swiss GLP Monitoring Authorities

Type of method:

Laser scattering/diffraction

Type of particle tested:

primary particle

Percentile:

other: D5

Mean:

< 20 µm

St. dev.:

2.182

Percentile:

D10

Mean:

< 29.5 µm

St. dev.:

2.855

Percentile:

D50

Mean:

< 78 µm

St. dev.:

4.723

Percentile:

D90

Mean:

< 154.9 µm

St. dev.:

3.514

Results

The test item is a white fine powder. Under the microscope (with a magnification of 400) squared, colourless, crystalline structures were observed.

 

A solubility test showed, that the test item is both sparingly soluble and well dispersible in water containing Sympatens SH0/400.

 

A comparison of the individual measurements and the results obtained using the laser diffraction showed no relevant difference. Therefore the study is considered to be valid and no further testing is necessary.

 

In conclusion, using laser diffraction apparatus to study the particle size of the test item in the range between 0.3 µm and 300 µm, the mass median diameter (MMD) was determined to be 78.0 µm.

 

The particle size distribution was found to range from approximately 0.3 µm to 250 µm.

Table 1: Particle size distribution of test item

%	Run 1 Particle size µm	Run 2 Particle size µm	Run 3 Particle size µm	Run 4 Particle size µm	Mean particle size µm	Standard deviation (+/-)
5	< 22.11	< 20.72	< 20.26	< 16.96	< 20.0	2.182
10	< 32.51	< 30.14	< 29.62	< 25.63	< 29.5	2.855
50	< 81.34	< 80.28	< 79.25	< 71.00	< 78.0	4.723
90	< 156.73	< 157.82	< 155.32	< 149.90	< 154.9	3.514

 

The MMD of the test item indicates that 50% of the particles are smaller than 78.0 µm.

 

Description of key information

Mass Median Diameter (MMAD) = 78.0 μm

Particle Size Distribution

D5: < 20.0 μm

D10: < 29.5 μm

D50: < 78.0 μm

D90: < 154.9 μm