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EC number: 213-485-0 | CAS number: 957-68-6
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study (ISO 13320-1) with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ISO 13320-1
- Deviations:
- no
- GLP compliance:
- no
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- 3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- EC Number:
- 213-485-0
- EC Name:
- 3-acetoxymethylen-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- Cas Number:
- 957-68-6
- Molecular formula:
- C10H12N2O5S
- IUPAC Name:
- (6R,7R)-3-[(acetyloxy)methyl]-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: 7-Aminocefalosporansäure (7-ACA)
Lot no.: 34212818
Constituent 1
Results and discussion
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:
- 0.97 µm
- Percentile:
- D50
- Mean:
- 5.37 µm
- Percentile:
- D90
- Mean:
- 75.38 µm
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- > 0.2 - < 20 µm
- Distribution:
- ca. 83 %
- No.:
- #2
- Size:
- > 20 - < 260 µm
- Distribution:
- ca. 17 %
Applicant's summary and conclusion
- Conclusions:
- The investigated product shows a bimodal partcle size distribution with a first maximum between 0.006 and 0.007 mm and second maximum between approximately 0.08 and 0.09 mm. The mean particle size D50 was determined to 0.005 mm.
- Executive summary:
The particle size distribution is determined using light scattering. As measuring device, a Malvern Mastersizer 2000 is used. The test is performed according to ISO 13320.
The powder is brought via a powder dispersing cell Scirocco into the laser light beam and the pattern is determined. In case the powder has a coarse grain fraction > 1000 µm, it is separated before the measurement is performed. The particle size distribution of the remaining fines is then determined.
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