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EC number: 942-582-7 | 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:
- 25-08-2017 to 30-08-2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- other: single crystalline particles
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- calcium dipotassium disodium trisulfate
- Molecular formula:
- SO42-, K+, Na+, Ca2+
- IUPAC Name:
- calcium dipotassium disodium trisulfate
- Test material form:
- solid
- Remarks:
- light to beige solid
Constituent 1
- Specific details on test material used for the study:
- - Analytical purity:100%
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: sodium (7.4g/100g of dry matter), Potassium (33.9g/100g of dry matter)), Ammonium (0.97g/100g of dry matter), Calcium (0.11g/100g of dry matter), Magnesium (<0.01g/100g of dry matter), Chloride (0.01g/100g of dry matter), Sulfates (60g/100g of dry matter), phosphates (<0.01g/100g of dry matter)
- Purity test date: 1 February 2017
- Lot/batch No.: EXP LIberica Lote Al16503047
- Expiration date of the lot/batch: November 2019
Results and discussion
- Mass median aerodynamic diameter:
- ca. 378.181 µm
- Geometric standard deviation:
- ca. 3.043
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- ca. 144.244 µm
- St. dev.:
- 1.889
- Key result
- Percentile:
- D50
- Mean:
- ca. 235.445 µm
- St. dev.:
- 1.894
- Key result
- Percentile:
- D90
- Mean:
- ca. 369.708 µm
- St. dev.:
- 1.816
Any other information on results incl. tables
The results of the formal analysis are presented in the following tables.
|
RUN 1 |
RUN 2 |
RUN 3 |
RUN 4 |
RUN 5 |
Average** |
Volume weighted mean |
244.117 |
245.403 |
243.986 |
248.076 |
248.075 |
245.932 |
Median |
233.527 |
235.288 |
233.208 |
237.474 |
237.708 |
235.445 |
Mode |
237.285 |
239.843 |
236.873 |
241.450 |
241.899 |
239.482 |
MMAD* |
375.1 |
377.929 |
374.587 |
381.44 |
381.816 |
378.181 |
d10 |
143.117 |
142.702 |
142.348 |
146.442 |
146.646 |
144.244 |
d50 |
233.527 |
235.288 |
233.208 |
237.474 |
237.708 |
235.445 |
d90 |
367.086 |
370.688 |
368.004 |
371.576 |
371.212 |
369.708 |
All results are in μm
* Mass median aerodynamic diameter
** Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
0.0 % by volume of sample was seen to be < 10.00 μm.
|
RUN 1 |
RUN 2 |
RUN 3 |
RUN 4 |
RUN 5 |
STDVP |
% STDVP |
d10 |
143.117 |
142.702 |
142.348 |
146.442 |
146.646 |
1.889 |
1.3 |
d50 |
233.527 |
235.288 |
233.208 |
237.474 |
237.708 |
1.894 |
0.8 |
d90 |
367.086 |
370.688 |
368.004 |
371.576 |
371.212 |
1.816 |
0.5 |
d15.78 |
159.692 |
159.947 |
158.987 |
163.032 |
163.297 |
1.804 |
1.1 |
GSD |
1.462 |
1.471 |
1.467 |
1.457 |
1.456 |
0.006 |
0.4 |
MMAD |
375.1 |
377.929 |
374.587 |
381.44 |
381.816 |
3.043 |
0.8 |
GSD = Geometric standard deviation of the lognormal particle size distribution (calculated from d50/d15.78)
STDVP = standard deviation of the population
% STDVP = percentage standard deviation of the population
Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.
Applicant's summary and conclusion
- Conclusions:
- The results of the formal analysis are (mean):
- d10 = 144.244 µm;
- d50 = 235.445 µm;
- d90 = 369.708 µm;
- MMAD = 378.181 µm. - Executive summary:
The particle size distribution of the test item has been studied in GLP compliance by laser diffraction method, according to the standard guidelines CIPAC MT 183, and ISO 13320. The results of the formal analysis are (mean):
- d10 = 144.244 µm;
- d50 = 235.445 µm;
- d90 = 369.708 µm;
- MMAD = 378.181 µm.
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