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Particle size distribution (Granulometry)

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Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-07-08 - 2002-07-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: European Commission, Document ECB/TM/February 1996: "Particle Size Distribution, Fibre Length and Diameter Distribution", Guidance Document, using the sieving method.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving
Type of particle tested:
agglomerate
Type of distribution:
mass based distribution
Specific details on test material used for the study:
- Storage condition of test material: at room temperature (at about 20 °C)
Key result
Percentile:
D50
Mean:
500 µm
St. dev.:
0
Remarks on result:
other: no St. dev. can be given
Remarks:
Determination was made via sieve test. The sieves had 75 µm, 125 µm, 250 µm, 500 µm, 1000 µm and 2000 µm mesh size, those are absolute values and no STD can be given.
Percentile:
other: D2
Mean:
<= 250 µm
St. dev.:
0
Remarks on result:
other: no St. dev. can be given
Remarks:
Determination was made via sieve test. The sieves had 75 µm, 125 µm, 250 µm, 500 µm, 1000 µm and 2000 µm mesh size, those are absolute values and no STD can be given.
No.:
#1
Size:
<= 500 µm
Distribution:
ca. 50 %

In conclusion it can be stated that the particles of 1,3-Dimethyl-4-aminouracil form various size agglomerates. The measurement of the single particles was not possible. The amount of test item with a particle size below 250 µm was only about 2 %. This amount is too small and not relevant for the particle size distribution. The main agglomerate size was found in the range of 250 µm to 2000 µm. 50 % of the test item agglomerates exceeded 500 µm.

Conclusions:
The GLP study was performed according to the European Commission, Document ECB/TM/February 1996: "Particle Size Distribution, Fibre Length and Diameter Distribution", Guidance Document, using the sieving method.
The particles of 1,3-Dimethyl-4-aminouracil form various size agglomerates. The main agglomerate size was found in the range of 250 µm to 2000 µm. 50 % of the test item agglomerates exceeded 500 µm.
Executive summary:

The GLP study was performed according to the European Commission, Document ECB/TM/February 1996: "Particle Size Distribution, Fibre Length and Diameter Distribution", Guidance Document, using the sieving method.

Based on the visual observation, the sieving method was selected to determine the particle size of the test substance.

In conclusion it can be stated that the particles of 1,3-Dimethyl-4-aminouracil form various size agglomerates. The measurement of the single particles was not possible. The amount of test item with a particle size below 250 µm was only about 2 %. This amount is too small and not relevant for the particle size distribution. The main agglomerate size was found in the range of 250 µm to 2000 µm. 50 % of the test item agglomerates exceeded 500 µm.

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP
Guideline:
other: laser diffraction according to ISO 13320-1, with evaluation according to Fraunhofer.
GLP compliance:
yes (incl. QA statement)
Other quality assurance:
other: ISO 13320-1
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution
Percentile:
D10
Mean:
19 µm
Remarks on result:
other: No source field for Standard deviation.
Percentile:
D50
Mean:
106 µm
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D90
Mean:
1 020 µm
Remarks on result:
other: No source field for Standard deviation.
No.:
#1
Size:
7.095 µm
Distribution:
0.09 %
No.:
#2
Size:
10 µm
Distribution:
1.25 %
No.:
#3
Size:
20 µm
Distribution:
11.7 %
No.:
#4
Size:
44.774 µm
Distribution:
31.85 %
No.:
#5
Size:
100 µm
Distribution:
48.95 %
No.:
#6
Size:
2 000 µm
Distribution:
100 %

Description of key information

Granulometry

- D10 = 19 µm, D50 = 106 µm, D90 = 1020 µm (volumetric distribution, laser diffraction according to ISO 13320-1)

- D2 <= 250 µm, D50 = 500 µm (mass based distribution, sieving method)

Additional information