Registration Dossier
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EC number: 258-416-5 | CAS number: 53179-11-6
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions)
- Principles of method if other than guideline:
- Particle Size Distribution (CIPAC MT 59 and OECD No. 110)
- GLP compliance:
- no
- Type of method:
- sedimentation (gravitational settling)
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- Loperamide
- EC Number:
- 258-416-5
- EC Name:
- Loperamide
- Cas Number:
- 53179-11-6
- Molecular formula:
- C29H33ClN2O2
- IUPAC Name:
- 4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test item identification : 4-(4-clorofenil)-4-idrossi-N,N-dimetil-a,a-difenil-1--piperidinbutanamide
Purity : 99.7 % w/w
Expiry date : June 01, 2015
Constituent 1
Results and discussion
Particle size
- Percentile:
- D50
- Remarks on result:
- other: Migrated from fields under 'Mass median diameter' as D50 percentile. No source field for Standard deviation.
Particle size distribution at different passagesopen allclose all
- No.:
- #1
- Size:
- > 500 µm
- Distribution:
- ca. 95 %
- No.:
- #2
- Size:
- > 45 µm
- Distribution:
- ca. 99 %
Applicant's summary and conclusion
- Conclusions:
- From the obtained experimental data according to CIPAC method MT 59 and OECD
guideline No. 110, it can be concluded that, after 5 minutes of shaking, the particle size
distribution of 4-(4-chlorophenyl)-4-hydroxy-N,N-dimethyl-a,a-diphenyl: about 95% of the
sample presents a particle size higher than 0.500 mm (500 m) and about 99% higher than
0.045 mm (45 m).
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