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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:
2018-12-07 to 2018-12-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 59 Sieve Analysis
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 170 Dry Sieve Analysis of Water Dispersible Granules
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: CIPAC MT 169 Tap Density of Water Dispersible Granules
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
OGYÉI- National Institute of Pharmacy and Nutrition (21.04.2016)
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:
Test item was used in its initial form.
No.:
#1
Size:
45 µm
Distribution:
0.39 %
No.:
#2
Size:
63 µm
Distribution:
3.5 %
No.:
#3
Size:
100 µm
Distribution:
32.94 %
No.:
#4
Size:
250 µm
Distribution:
52.25 %
No.:
#5
Size:
500 µm
Distribution:
8.79 %
No.:
#6
Size:
1 000 µm
Distribution:
0.26 %
No.:
#7
Size:
2 000 µm
Distribution:
0.27 %
No.:
#8
Size:
4 000 µm
Distribution:
0.25 %

The tap density of the test item was found to be 0.52 g/mL. Details are summarized in Table 1.

The particle size distribution of the test item was found to be in the range of 100 to 500 μm. Details are summarized in Table 2.

Table 1. Tap density determination

Sample mass (W) 80.5 g
Sample volume after dropping (V) 156 mL
Tap density (D) 0.52 g/mL

Table 2. Sieve test

Number of sieves (n): 8
Sample mass (m calculated): 82.6 g
Samples mass (weighed): 83.66 g
Sieve Residue mass gx(g) Residue rx(m/m) % Sum of residues Rx(m/m) %
Size (µm) 
< 45

 

0.03

0.04

98.69

45

 

0.33

0.39

98.65

63

 

2.93

3.50

98.25

100

 

27.56

32.94

94.75

250

 

43.70

52.24

61.81

500

 

7.35

8.79

9.57

1000

 

0.22

0.26

0.79

2000

 

0.23

0.27

0.53

4000

 

0.21

0.25

0.25
Conclusions:
The particle size distribution of the test item was found to be between 100 μm and 500 μm.
Executive summary:

The determination of the Particle Size Distribution of the test item was conducted following internationally accepted guidelines (CIPAC MT 59 Sieve Analysis, CIPAC MT 170 Dry Sieve Analysis of Water Dispersible Granules, CIPAC MT 169 Tap Density of Water Dispersible Granules) under GLP compliance.

Machine sieving test was carried out using the following test sieves 4, 2, 1 mm, 500, 250, 100, 63 and 45 μm.

The particle size distribution of the test item was found to be: between 100 μm and 500 μm.

Description of key information

The determination of the Particle Size Distribution of the test item was conducted following internationally accepted guidelines (CIPAC MT 59 Sieve Analysis, CIPAC MT 170 Dry Sieve Analysis of Water Dispersible Granules, CIPAC MT 169 Tap Density of Water Dispersible Granules) under GLP compliance.

Machine sieving test was carried out using the following test sieves 4, 2, 1 mm, 500, 250, 100, 63 and 45 μm.

The particle size distribution of the test item was found to be: between 100 μm and 500 μm.

Additional information