Registration Dossier
Registration Dossier
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EC number: 606-460-4 | CAS number: 201855-65-4
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:
- (-)-3R,4R-1-Benzyl-4-(4-fluorophenyl)-3-hydroxymethyl-piperide-L-dibenzoyl tartrate
- EC Number:
- 606-460-4
- Cas Number:
- 201855-65-4
- Molecular formula:
- C19H22FNO + C18H14O8 = C37H36FNO9
- IUPAC Name:
- (-)-3R,4R-1-Benzyl-4-(4-fluorophenyl)-3-hydroxymethyl-piperide-L-dibenzoyl tartrate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch number: L63095NStorage conditions: 15-30 °C
Results and discussion
- Remarks on result:
- not measured/tested
Particle sizeopen allclose all
- Percentile:
- D10
- Mean:
- < 0.181 mm
- St. dev.:
- 0
- Percentile:
- D50
- Mean:
- < 0.295 mm
- St. dev.:
- 0
- Percentile:
- D90
- Mean:
- < 0.456 mm
- St. dev.:
- 0
Particle size distribution at different passages
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
