Registration Dossier
Registration Dossier
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EC number: 200-064-1 | CAS number: 50-78-2
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not performed in GLP, but according to current guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Laser diffraction (SympaTec apparatus)
- GLP compliance:
- no
- Type of distribution:
- mass based distribution
Test material
- Reference substance name:
- O-acetylsalicylic acid
- EC Number:
- 200-064-1
- EC Name:
- O-acetylsalicylic acid
- Cas Number:
- 50-78-2
- Molecular formula:
- C9H8O4
- IUPAC Name:
- 2-acetoxybenzoic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Rhodine 3020 and Rhodine 3080
- Physical state: crystalline
- Analytical purity: o-acetylsalicylic acid > 99.5 %
- Lot/batch No.: 3 lots od both qualities:
Rhodine 3080: lots FRH 1304908, FRH 1305308, FRH 1305708
Rhodine 3020: lots FRH 1305811, FRH 1306011, FRH 1306111
Constituent 1
Results and discussion
- Geometric standard deviation:
- 1.88 - 1.91
Particle sizeopen allclose all
- Percentile:
- D50
- Mean:
- 117.02 - 128.17 µm
- Remarks on result:
- other: Data for 3 lots of lowest particle size grade: Rhodine 3080(migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.)
- Percentile:
- D10
- Mean:
- 31.18 - 38.19 µm
- Percentile:
- D90
- Mean:
- 266.01 - 284.8 µm
Any other information on results incl. tables
Data for 3 lots of Rhodine 3020:
Mass median diameter: 429.83 - 466.89 µm
Presence of particles < 10 µm
Rhodine 3080: < 4 %
Rhodine 3020: < 1 %
Applicant's summary and conclusion
- Conclusions:
- Mass median diaùeter of Rhodine 3080: 117.02 to 128.17 µm, and Rhodine 3020: 429.83 - 466.89 µm
Particle < 10 µm: Rhodine 3080 < 4 % and Rhodine 3020 < 1 %
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