Registration Dossier

Physical & Chemical properties

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:
2016
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

Constituent 1
Chemical structure
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
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