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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:
11 July - 20 July 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions
Deviations:
no
Qualifier:
according to
Guideline:
other: CIPAC MT 170
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
sieving
Type of particle tested:
primary particle
Type of distribution:
mass based distribution
Specific details on test material used for the study:
- Test material: Balsalazide acid
- Batch number: 0400
- Expiry date: April 2019
- Storage: Room temperature
No.:
#1
Size:
> 4.75 mm
Distribution:
10.8 %
No.:
#2
Size:
> 3.35 mm
Distribution:
30.67 %
No.:
#3
Size:
> 2 mm
Distribution:
67.25 %
No.:
#4
Size:
> 1 mm
Distribution:
90.4 %
No.:
#5
Size:
> 250 µm
Distribution:
98.07 %
No.:
#6
Size:
> 75 µm
Distribution:
99.29 %
No.:
#7
Size:
< 75 µm
Distribution:
0.29 %

Table 1: Particle size distribution

Sieve

(mm)

Weight of the residue on the sieve

(g)

rx

Residue on the sieve

(%)

Rx

Sum of the residue

(%)

4.750

5.60

10.80

10.80

3.350

10.30

19.86

30.67

2.000

18.97

36.59

67.25

1.000

12.00

23.14

90.40

0.250

3.98

7.68

98.07

0.075

0.63

1.22

99.29

<0.075

0.15

0.29

99.58

 

 

Conclusions:
The particle size distribution of Balsalazide acid sample is: 10.80% of the sample presents a particle size higher than 4.750 mm, 30.67% of the sample presents a particle size higher than 3.350 mm, 67.25% of the sample presents a particle size higher than 2.000 mm, 90.40% of the sample presents a particle size higher than 1.000 mm, 98.07% of the sample presents a particle size higher than 0.250 mm (250 µm), 99.29% of the sample presents a particle size higher than 0.075 mm (75 µm) and 0.29% of the sample was found under 0.075 mm (75 µm).

Description of key information

The particle size distribution of the test item, Balsalazide acid was determined according to OECD Guideline 110 and CIPAC Method MT 170. It can be concluded that, after 5 minutes of shaking, the particle size distribution of Balsalazide acid sample is: 10.80% of the sample presents a particle size higher than 4.750 mm, 30.67% of the sample presents a particle size higher than 3.350 mm, 67.25% of the sample presents a particle size higher than 2.000 mm, 90.40% of the sample presents a particle size higher than 1.000 mm, 98.07% of the sample presents a particle size higher than 0.250 mm (250 µm), 99.29% of the sample presents a particle size higher than 0.075 mm (75 µm) and 0.29% of the sample was found under 0.075 mm (75 µm).

Additional information