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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ISO 13320-1
Principles of method if other than guideline:
The determination of the particle size distribution was carried out by Iaser diffraction according to ISO 13320-1 with evaluation according to
Fraunhofer.
GLP compliance:
yes (incl. QA statement)
Type of distribution:
volumetric distribution

Test material

Constituent 1
Chemical structure
Reference substance name:
Pseudoephedrine
EC Number:
202-018-6
EC Name:
Pseudoephedrine
Cas Number:
90-82-4
Molecular formula:
C10H15NO
IUPAC Name:
(1S,2S)-2-(methylamino)-1-phenylpropan-1-ol
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): ( + )-Pseudoephedrine
- Physical state: solid
- Analytical purity: 99.9 %
- Lot/batch No.: 023513AX20

Results and discussion

Particle sizeopen allclose all
Percentile:
D50
Remarks on result:
other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Percentile:
D10
Mean:
94 µm
Percentile:
D50
Mean:
325 µm
Percentile:
D90
Mean:
778 µm
Particle size distribution at different passagesopen allclose all
No.:
#1
Size:
30.2 µm
Distribution:
0.11 %
No.:
#2
Size:
50 µm
Distribution:
1.86 %
No.:
#3
Size:
91.201 µm
Distribution:
9.98 %
No.:
#4
Size:
156.489 µm
Distribution:
22.07 %
No.:
#5
Size:
363.078 µm
Distribution:
55.49 %

Any other information on results incl. tables

< 100 µm: 11.1 % < 10 µm: 0 % ; < 4 µm: 0%

Applicant's summary and conclusion