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EC number: 606-459-9 | CAS number: 201855-57-4
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US PHARMACOPEIA 786, Ph.Eur 2.9.38
- GLP compliance:
- no
- Type of method:
- sieving
- Type of distribution:
- mass based distribution
Test material
- Reference substance name:
- (-)-1-Benzyl-4-(-4-fluor-phenyl)-3-hydroxymethyl-1,2,3,6-tetrahydropyridine-L-dibenzoyl-tartaric salt
- EC Number:
- 606-459-9
- Cas Number:
- 201855-57-4
- Molecular formula:
- C37H34FNO9
- IUPAC Name:
- (-)-1-Benzyl-4-(-4-fluor-phenyl)-3-hydroxymethyl-1,2,3,6-tetrahydropyridine-L-dibenzoyl-tartaric salt
- Test material form:
- solid: crystalline
1
- Specific details on test material used for the study:
- Batch number: L63046NStorage conditions: 15-30 °C
Results and discussion
- Remarks on result:
- not measured/tested
Particle sizeopen allclose all
- Percentile:
- D10
- Mean:
- < 0.087 mm
- St. dev.:
- 0
- Percentile:
- D50
- Mean:
- < 0.125 mm
- St. dev.:
- 0
- Percentile:
- D90
- Mean:
- < 0.171 mm
- St. dev.:
- 0
Particle size distribution at different passages
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
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