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Diss Factsheets

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:
2018
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
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
GLP compliance:
no
Type of method:
Laser scattering/diffraction
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
α-phenylpiperidine-2-acetic acid
EC Number:
243-020-7
EC Name:
α-phenylpiperidine-2-acetic acid
Cas Number:
19395-41-6
Molecular formula:
C13H17NO2
IUPAC Name:
α-phenylpiperidine-2-acetic acid
Test material form:
solid: granular

Results and discussion

Particle sizeopen allclose all
Percentile:
D90
Mean:
35.13 µm
Remarks on result:
other: st.dev. not specified
Percentile:
D50
Mean:
9.01 µm
Remarks on result:
other: st.dev. not specified
Percentile:
D10
Mean:
2.39 µm
Remarks on result:
other: st.dev. not specified
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
> 0.142 - < 0.159 µm
Distribution:
0.02 %
No.:
#2
Size:
> 0.502 - < 0.564 µm
Distribution:
0.29 %
No.:
#3
Size:
> 1.589 - < 1.783 µm
Distribution:
0.95 %
No.:
#4
Size:
> 6.325 - < 7.096 µm
Distribution:
4.3 %
No.:
#5
Size:
> 25.179 - < 28.251 µm
Distribution:
2.6 %
No.:
#6
Size:
> 100.237 - < 112.468 µm
Distribution:
0.12 %

Any other information on results incl. tables

Tests were conducted dispersing the sample labelled asRitalinic Acidusing the specific sampling unit called SCIROCCO 2000. The results of the determination on the sample labelled as Ritalinic Acid are shown in the attached figure.

The figure shows the average volume diameter as well as that for which the accumulative particle size distribution assumes a respective value of 90%, 50% and 10% in addition to the differential distribution for each fraction and the corresponding graph as well as the measurement parameters and the indications of the powder sample and the operator.

In Table 1, the average volume diameter is found as well as that for which the accumulative particle size assumes a respective value of 90%, 50% and 10%.

Table 1_Characteristic diameters of the particle size distribution on the sample Ritalinic Acid

SAMPLE

D[4,3]

micrometre

d(90%) 

micrometre

d(50%) 

micrometre

d(10%) 

micrometre

Ritalinic Acid

14,70

35,13

9,01

2,39

Applicant's summary and conclusion

Conclusions:
Particle size distribution of the substance is : D90 = 35.13 micrometre; D50 = 9.01 micrometre; D10 = 2.39 micrometre.