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:
(-)-1β-2(2´-Diethoxy-carbonyl-ethyl)-1α-ethyl-1,2,3,4,6,7,12,12b-α-octahydro-indolo[2,3-a]quinolizin
EC Number:
603-912-2
Cas Number:
135266-72-7
Molecular formula:
C25H34N2O4
IUPAC Name:
(-)-1β-2(2´-Diethoxy-carbonyl-ethyl)-1α-ethyl-1,2,3,4,6,7,12,12b-α-octahydro-indolo[2,3-a]quinolizin

Results and discussion

Remarks on result:
not determinable
Particle sizeopen allclose all
Percentile:
D10
Mean:
<= 142 µm
St. dev.:
0
Percentile:
D50
Mean:
<= 245 µm
St. dev.:
0
Percentile:
D90
Mean:
<= 602 µm
St. dev.:
0
Particle size distribution at different passages
Remarks on result:
not measured/tested

Applicant's summary and conclusion