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Physical & Chemical properties

Particle size distribution (Granulometry)

Administrative data

Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: CIPAC method MT 59 and MT 170
Principles of method if other than guideline:
The certified sieves were assembled in the correct order with the coarsest at the top and the finest at the bottom and mounted on the receiver pan. Using the technical balance, 52.88 g of the dry test item was weighed and placed into the coarsest sieve. The lid was fitted to the nest of sieves and it was put into the shaking apparatus. The shaker was started and run for 5 minutes. That time elapsed, the sieves were removed and the test item in each sieve was weighed again on the technical balance.
GLP compliance:
no
Type of method:
sieving
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
Salbutamol
EC Number:
242-424-0
EC Name:
Salbutamol
Cas Number:
18559-94-9
Molecular formula:
C13H21NO3
IUPAC Name:
4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol
Test material form:
solid: particulate/powder

Results and discussion

Mass median aerodynamic diameter:
µm
Particle size
Percentile:
D99
Mean:
> 45 µm
St. dev.:
0
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
> 0.5 mm
Distribution:
ca. 16.21 %
No.:
#2
Size:
> 0.355 - < 0.5 mm
Distribution:
ca. 20.23 %
No.:
#3
Size:
> 0.25 - < 0.355 mm
Distribution:
ca. 21.44 %
No.:
#4
Size:
> 0.125 - < 0.25 mm
Distribution:
ca. 34.1 %
No.:
#5
Size:
> 0.075 - < 0.125 mm
Distribution:
ca. 6.73 %
No.:
#6
Size:
> 45 - < 75 µm
Distribution:
ca. 0.47 %

Applicant's summary and conclusion

Conclusions:
From the obtained experimental data according to CIPAC method MT 59 and MT 170, it can be concluded that, after 5 minutes of shaking, the particle size distribution of Salbutamol base is: 16.21% of the sample presents a particle size higher than 0.500 mm (500 μm), 36.44% of the sample presents a particle size higher than 0.355 mm (350 μm), 57.89% of the sample presents a particle size higher than 0.250 mm (250 μm), 91.98% of the sample presents a particle size higher than 0.125 mm (125 μm), 98.71% of the sample presents a particle size higher than 0.075 mm (75 μm), 99.19% of the sample presents a particle size higher than 0.045 mm (45 μm) and 0.00% of the sample was found under 0.045 mm (45 μm).