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EC number: 946-767-3 | CAS number: -
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to an internationally recognised method. The substance is considered to be adequately characterised. Therefore full validation applies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Deviations:
- no
- Principles of method if other than guideline:
- N/A
- GLP compliance:
- no
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- agglomerate
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- Saccharides of mannose and galactose from Ceratonia Siliqua seed
- IUPAC Name:
- Saccharides of mannose and galactose from Ceratonia Siliqua seed
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: beige powder
- Storage: in a dark place at room temperature
- Batch : 14 262
- Manufacturing date: September 19th 2014
- Expiry date: September 19th 2018
Constituent 1
- Specific details on test material used for the study:
- - Particle size: non spherical
- Particle size refractive index: 1.538 (sugars)
- Particle size absorption index: 0.010 (sugars)
- Approximate density of the powder: 1 g/cm3
Results and discussion
Particle sizeopen allclose all
- Key result
- Percentile:
- D50
- Mean:
- ca. 120 µm
- St. dev.:
- 0.4
- Key result
- Percentile:
- D10
- Mean:
- ca. 69.2 µm
- St. dev.:
- 0.1
- Key result
- Percentile:
- D90
- Mean:
- ca. 200 µm
- St. dev.:
- 1.4
Applicant's summary and conclusion
- Conclusions:
- The particle size distribution of the test substance was determined by laser diffraction according to ISO 13320-2009.
The test item has a median particle size D50 = 120.0 μm. - Executive summary:
The particle size distribution of the test substance was determined by laser diffraction according to ISO13320-2009 in an appropriate dispersive solvent (isopropanol).
The MIE diffusion model was used to obtain the volumetric distribution of the test substance.
5 measurements were made during the passage of the powder in the apparatus, the following parameters were determined:
D10= 69.2 µm (RSD = 0.14%)
D50= 120.0 µm (RSD = 0.31%)
D90= 200.0 µm (RSD = 0.72%)
All the RSD were below the limits definied by the ISO 13320, these measurements are considered to comply with the International Standard.
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