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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:
08.12.2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: CIPAC MT 187
GLP compliance:
yes (incl. certificate)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Particle sizeopen allclose all
Key result
Percentile:
D10
Mean:
2.689 µm
St. dev.:
0.114
Remarks on result:
other: mean of two measurements
Key result
Percentile:
D50
Mean:
13.189 µm
St. dev.:
0.461
Remarks on result:
other: mean of two measurements
Key result
Percentile:
D90
Mean:
42.853 µm
St. dev.:
0.565
Remarks on result:
other: mean of two measurements

Any other information on results incl. tables

Particle Size Distribution

Measurement

L10 D(v, 0.1)

[µm]

L50 D(v, 0.5)

[µm]

L90 D(v, 0.9)

[µm]

1

2.769

13.515

43.252

2

2.608

12.863

42.453

Mean Value

2.689

13.189

42.853

Applicant's summary and conclusion

Conclusions:
The L10 D (v, 0.1) was determined to be 2.689 µm, the L50 D (v, 0.5) was determined to be 13.189 µm and the L90 D (v, 0.9) was determined to be 42.853 µm.
Executive summary:

The particle size distribution was determined using the laser diffraction method with dry dispersion. The particle size distribution of L-Tyrosine was determined following CIPAC MT 187 and in compliance to GLP. The dispersing pressure was adjusted to 3.0 bar and the feeding rate was 50 %.

For the volume based particle size distribution the following results were obtained. The L10 D (v, 0.1) was determined to be 2.689 µm, the L50 D (v, 0.5) was determined to be 13.189 µm and the L90 D (v, 0.9) was determined to be 42.853 µm.