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:
(4aR,4bS,6aS,7aS,8aS,8bR,8cR)-2-methoxy-4a,6a-dimethyl-4,4a,4b,5,6,6a,7a,8,8a,8b,8c,9-dodecahydrocyclopropa[4,5]cyclopenta[1,2-a]phenanthren-7(3H)-one
EC Number:
607-934-3
Cas Number:
26441-40-7
Molecular formula:
C21H28O2
IUPAC Name:
(4aR,4bS,6aS,7aS,8aS,8bR,8cR)-2-methoxy-4a,6a-dimethyl-4,4a,4b,5,6,6a,7a,8,8a,8b,8c,9-dodecahydrocyclopropa[4,5]cyclopenta[1,2-a]phenanthren-7(3H)-one
Test material form:
solid: crystalline

Results and discussion

Remarks on result:
not measured/tested
Particle sizeopen allclose all
Percentile:
D10
Mean:
< 0.136 mm
St. dev.:
0
Percentile:
D50
Mean:
< 0.226 mm
St. dev.:
0
Percentile:
D90
Mean:
< 0.498 mm
St. dev.:
0
Particle size distribution at different passages
Remarks on result:
not measured/tested

Applicant's summary and conclusion