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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:
21.08.2018 - 22.08.2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
equivalent or similar to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
Version / remarks:
CTL SOP No. 417:
To characterise the particle size distribution of the test item. The analysis is conducted initially using a visual microscope and is then undertaken more formally using a Laser Diffraction Particle Size Analyser. The benefit of this procedure is that it allows the operator to obtain a better understanding of the particle characterisation of the material.
This includes, but is not limited to, sample clusters and agglomerations which may provide false values in the formal particle size analysis. In these situations, where the operator can assess how easily these clusters or agglomerations are dispersed, ultrasonics may be employed. Owing to the extremely small quantities of material used in this analysis it should be noted that discrepancies can arise between the lower and upper limits of the particle size and the actual value obtained in the formal particle size analysis.

GLP compliance:
yes (incl. QA statement)
Type of method:
microscopic examination
Remarks:
The test item is observed under 3 conditions: • Direct observation • Under a microscope at 100 x magnification • Under a microscope at 400 x magnification
Type of particle tested:
other: liquid
Remarks:
Sample was vacuum dried at 50 - 70°C but found to have transformed into a gloopy paste. Therefore, the sample was analysed in the as received condition for the particle size determination.
Type of distribution:
other: not determinated
Remarks on result:
not determinable
Remarks:
No particulates could be observed in the liquid, therefore the test item is a solution and not a suspension. Particle size analysis is therefore not feasible.
Key result
Remarks on result:
not determinable
Remarks:
No particulates could be observed in the liquid, therefore the test item is a solution and not a suspension. Particle size analysis is therefore not feasible.
Remarks on result:
not determinable
Remarks:
No particulates could be observed in the liquid, therefore the test item is a solution and not a suspension. Particle size analysis is therefore not feasible.
Conclusions:
No particulates could be observed in the liquid, therefore the test item is a solution and not a suspension. Particle size analysis is therefore not feasible.
Executive summary:

As the test item forms a paste or solid mass upon drying/ removal of water, particle size analysis is not possible on the dried test item without artificially micronizing the test item. The test results on any mechanically altered test item would be subjective and not representative or valid for the test item.

Description of key information

Particle size analysis is not feasible. Substance is a gloopy paste.

Additional information