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EC number: 222-848-2 | CAS number: 3632-91-5
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 19 to 22 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- ISO 13320 (Particle size analysis - Laser diffraction methods)
- GLP compliance:
- not specified
- Other quality assurance:
- ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
- Type of method:
- electrical sensing zone (e.g. Coulter) method
- Type of particle tested:
- primary particle
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- Magnesium digluconate
- EC Number:
- 222-848-2
- EC Name:
- Magnesium digluconate
- Cas Number:
- 3632-91-5
- Molecular formula:
- C6H12O7.1/2Mg
- IUPAC Name:
- magnesium digluconate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 1500000655
- Expiration date of the lot/batch: 13.03.2018
- Manufacturing date: 14.03.2015
Results and discussion
- Mass median aerodynamic diameter:
- 19.36 µm
- Geometric standard deviation:
- 30.45
Particle sizeopen allclose all
- Percentile:
- D10
- Mean:
- 2.73 µm
- St. dev.:
- 30.45
- Percentile:
- D50
- Mean:
- 19.36 µm
- St. dev.:
- 30.45
- Percentile:
- D90
- Mean:
- 63.99 µm
- St. dev.:
- 30.45
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- 10 µm
- Distribution:
- 29.8 %
- No.:
- #2
- Size:
- 20 µm
- Distribution:
- 51.2 %
- No.:
- #3
- Size:
- 25 µm
- Distribution:
- 59.7 %
- No.:
- #4
- Size:
- 32 µm
- Distribution:
- 69 %
- No.:
- #5
- Size:
- 50 µm
- Distribution:
- 83.7 %
- No.:
- #6
- Size:
- 63 µm
- Distribution:
- 89.7 %
- No.:
- #7
- Size:
- 71 µm
- Distribution:
- 92 %
- No.:
- #8
- Size:
- 75 µm
- Distribution:
- 92.8 %
- No.:
- #9
- Size:
- 90 µm
- Distribution:
- 95.1 %
- No.:
- #10
- Size:
- 100 µm
- Distribution:
- 96 %
Applicant's summary and conclusion
- Conclusions:
- The median particle size D50 of the test item deduced from the particle size distributions was : 19.36 micrometer.
The particle size D10 of the test item deduced from the particle size distributions was : 2.730 micrometer.
The particle size D90 of the test item deduced from the particle size distributions was : 63.99 micrometer. - Executive summary:
The particle size distribution of magnesium gluconate was determined following ISO 13320 (Particle size analysis - Laser diffraction methods).
The particle size distributions were determined in a test serie. For the test serie fraction (left axis of the ordinate) and the shiftings (right axis of the ordinate) are presented in percent by volume as a function of the particle size. Median value was calculated from unrounded values.
The median particle size D50 of the test item deduced from the particle size distributions was : 19.36 micrometer.
The particle size D10 of the test item deduced from the particle size distributions was : 2.730 micrometer.
The particle size D90 of the test item deduced from the particle size distributions was : 63.99 micrometer.
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