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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:
2017-01-26 to 2017-01-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 170 Dry Sieve Analysis of Water Dispersible Granules, CIPAC Handbook Volume F
Version / remarks:
1995
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
sieving
Type of particle tested:
other: powder
Type of distribution:
mass based distribution
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Changzhou Sunlight Pharmaceutical Co., Ltd., China; 20160505 / 116727
- Expiration date of the lot/batch: May 2017
- Purity test date: 30.01.2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: stable
Key result
Percentile:
D10
Mean:
> 4 000 µm
Remarks on result:
other: St. dev. not given
Key result
Percentile:
D90
Mean:
100 µm
Remarks on result:
other: St. dev. not given
No.:
#1
Size:
45 µm
Distribution:
0.2 %
No.:
#2
Size:
63 µm
Distribution:
2.9 %
No.:
#3
Size:
100 µm
Distribution:
28.4 %
No.:
#4
Size:
250 µm
Distribution:
35.8 %
No.:
#5
Size:
500 µm
Distribution:
8.8 %
No.:
#6
Size:
1 000 µm
Distribution:
3.4 %
No.:
#7
Size:
2 000 µm
Distribution:
6.7 %
No.:
#8
Size:
4 000 µm
Distribution:
12.4 %
Conclusions:
Using the dry sieve analysis in order to determine the particle size distribution of the test substance a range of 100 μm to over 4000 μm was found which covers at least 80 % of the particle size distribution.
Executive summary:

The particle size distribution was determined according to the recommendations indicated in CIPAC MT 170 (1995) (TOXICOOP, 2017). In a first step the tap density was determined, which was required for the calculation of sample mass for the sieve test. The particle size distribution was evaluated for the determined sample mass using a nest of 8 sieves and a sieving machine (5 min period). The amount of test substance in each sieve was determined by weighting the retained substance. For the particle size distribution of the test substance it was determined that at least 80 % of the particles were in the range of 100 to over 4000 μm.

Description of key information

Using the dry sieve analysis in order to determine the particle size distribution of the test substance, a range of 100 μm to over 4000 μm was found which covers at least 80 % of the particle size distribution.

Additional information

The particle size distribution was determined according to the recommendations indicated in CIPAC MT 170 (1995) (TOXICOOP, 2017). In a first step the tap density was determined, which was required for the calculation of sample mass for the sieve test. The particle size distribution was evaluated for the determined sample mass using a nest of 8 sieves and a sieving machine (5 min period). The amount of test substance in each sieve was determined by weighting the retained substance. For the particle size distribution of the test substance it was determined that at least 80 % of the particles were in the range of 100 to over 4000 μm.