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EC number: 241-155-6 | CAS number: 17090-93-6
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187 / SPO/BF/24/b
- Version / remarks:
- CIPAC MT 187 / SPO/BF/24/b
- Principles of method if other than guideline:
- 5.2.1. Apparatus
Apparatus used: Coulter LS 13 320 and common laboratory equipment.
5.2.2. Description of the Method
The particle size analysis test was performed in accordance to a test procedure no. SPO/BF/24/b (ed. 4) based in CIPAC MT 187 using Coulter LS 13 320 with ULM (Universal Liquid Model).
A representative sample of the test item is dispersed at an adequate concentration in a suitable liquid, is passed through the beam of a monochromatic light source, a laser. The light scattered by the particles at various angles is measured by a multi-element detector and numerical, values relating to the scattering pattern are then recorded for subsequent analysis. These numerical scattering values are then transformed, using an appropriate optical model and mathematical procedure, to yield the proportion of total volume to a discrete number of size classes forming a volumetric particle size distribution. - GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- sodium 2-amino-3-carboxypropanoate
- Cas Number:
- 323194-76-9
- Molecular formula:
- C4H7NO4.xNa
- IUPAC Name:
- sodium 2-amino-3-carboxypropanoate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name: L-aspartic acid, sodium salt monohydrate 1
Batch/Lot number: Z201125/ VG29848563
CAS number: 323194-76-9
Anhydrous substance name: L-aspartic acid, sodium salt, CAS: 17090-93-6
Appearance: Solid, white, crystalline powder
Purity: 98%
Expiry date: 24 November 2022
Storage conditions: Room temperature (15-25 ºC), protected from humidity (tight closed
container)
Constituent 1
Results and discussion
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- ca. 15.558 µm
- St. dev.:
- 0.081
- Key result
- Percentile:
- D50
- Mean:
- ca. 112.74 µm
- St. dev.:
- 0.313
- Key result
- Percentile:
- D90
- Mean:
- ca. 255.22 µm
- St. dev.:
- 1.15
Any other information on results incl. tables
The results of the particle size distribution test of the test item are presented in Table 4.
Table 4. Results of particle size distribution
Particles size | Test number and fraction size [µm] | |||||||
1 | 2 | 3 | 4 | 5 | Average | Standard deviation [µm] | Relative Standard Deviation, [%] | |
d10 [µm] | 15.68 | 15.56 | 15.58 | 15.49 | 15.48 | 15.558 | 0.081 | 0.521 |
d50 [µm] | 112.4 | 112.4 | 112.9 | 113.0 | 113.0 | 112.740 | 0.313 | 0.278 |
d90 [µm] | 253.8 | 256.4 | 255.7 | 256.0 | 254.2 | 255.220 | 1,150 | 0.451 |
* d4,3 [µm] | 126.1 | 127.8 | 127.6 | 128.0 | 126.4 | 127.18 | 0.867 | 0.682 |
* Average d4,3 [µm] – The mass moment mean (De Brouckere Mean Diameter)
Applicant's summary and conclusion
- Conclusions:
- The results of the particle size distribution test
d10 [µm] 15.558 µm
d50 [µm] 112.740 µm
d90 [µm] 255.220 µm - Executive summary:
Description of the Method
The particle size analysis test was performed in accordance to a test procedure no.SPO/BF/24/b (ed. 4) based in CIPAC MT 187 using CoulterLS 13 320 with ULM (Universal Liquid Model).
A representative sample of the test item is dispersed at an adequate concentration in a suitable liquid, is passed through the beam of a monochromatic light source, a laser. The light scattered by the particles at various angles is measured by a multi-element detector and numerical, values relating to the scattering pattern are then recorded for subsequent analysis. These numerical scattering values are then transformed, using an appropriate optical model and mathematical procedure, to yield the proportion of total volume to a discrete number of size classes forming a volumetric particle size distribution.
The results of the particle size distribution test
d10 [µm] 15.558 µm
d50 [µm] 112.740 µm
d90 [µm] 255.220 µmParticle size distribution
CIPAC MT 187 / SPO/BF/24/b
Average d4,3, [µm]
127.18
CIPAC MT 187 / SPO/BF/24/b Standard deviation, [µm]
0.867
CIPAC MT 187 / SPO/BF/24/b Relative Standard Deviation, [%]
0.68
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