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Physical & Chemical properties

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:
03. Apr. - 15. Nov. 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions - Method A: Particle Size Distribution (effective hydrodynamic radius)
Qualifier:
according to guideline
Guideline:
ISO 13320 (Particle size analysis - Laser diffraction methods)
GLP compliance:
yes (incl. QA statement)
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
volumetric distribution
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 160805
- Expiration date of the lot/batch: 05 August 2018
- Purity test date: not stated

RADIOLABELLING INFORMATION (if applicable)
not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature, keep away from humidity
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none
Key result
Percentile:
D10
Mean:
72 µm
St. dev.:
1.27
Remarks on result:
other:
Key result
Percentile:
D50
Mean:
310.9 µm
St. dev.:
7.21
Key result
Percentile:
D90
Mean:
656.2 µm
St. dev.:
6.5
Conclusions:
The test item TREHALOSE, ANHYDROUS has a median particle size of D50= 311 μm,
which was determined by laser diffraction measurement

Description of key information

guideline study,

The median particle size is determined to be D50= 311 μm

Additional information