Registration Dossier
Registration Dossier
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EC number: 227-615-9 | CAS number: 5908-81-6
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 20, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 13320:2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: CIPAC MT 187
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- Barium tartrate
- EC Number:
- 227-615-9
- EC Name:
- Barium tartrate
- Cas Number:
- 5908-81-6
- Molecular formula:
- C4H4O6Ba
- IUPAC Name:
- Barium L(+)-(2R,3R)-tartrate
- Details on test material:
- - Name of test material (as cited in study report): Barium Tartrate
- Appearance: White powder
Constituent 1
Results and discussion
- Mass median aerodynamic diameter:
- 221.933 - 224.184 µm
- Geometric standard deviation:
- 1.768 - 1.775
Particle sizeopen allclose all
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
- Percentile:
- D10
- Mean:
- 57.372 µm
- St. dev.:
- 0.138
- Remarks on result:
- other: Population standard deviation [µm]
- Percentile:
- D50
- Mean:
- 128.42 µm
- St. dev.:
- 0.424
- Remarks on result:
- other: Population standard deviation [µm]
- Percentile:
- D90
- Mean:
- 228.934 µm
- St. dev.:
- 1.879
- Remarks on result:
- other: Population standard deviation [µm]
Particle size distribution at different passages
- Size:
- < 10 µm
- Distribution:
- 2.73 %
- Remarks on result:
- other: By volume
Any other information on results incl. tables
MMAD mean: 223.171 µm (population standard deviation: 0.74 µm)
Mode: 139.338 µm
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:
- In a GLP-compliant study in accordance with ISO 13320 and CIPAC MT 187 using laser diffraction analysis (dry powder module), the particle size distribution of the substance was determined: 2.7% is < 10.00 µm; 10% is < 57.4 µm; 50% is < 128.4 µm and 90% is < 228.9 µm. The MMAD is 223.2 µm.
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