Registration Dossier

Diss Factsheets

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:
1,3-Dichloro-2-(2,4-difluoro-phenyl-propan-2-ol
EC Number:
617-842-5
Cas Number:
86386-74-5
Molecular formula:
C9H8Cl2F2O
IUPAC Name:
1,3-Dichloro-2-(2,4-difluoro-phenyl-propan-2-ol
Test material form:
solid: particulate/powder

Results and discussion

Remarks on result:
not determinable
Particle sizeopen allclose all
Percentile:
D10
Mean:
<= 255 µm
St. dev.:
0
Percentile:
D50
Mean:
<= 712 µm
St. dev.:
0
Percentile:
D90
Mean:
<= 1 295 µm
St. dev.:
0
Particle size distribution at different passages
Remarks on result:
not measured/tested

Applicant's summary and conclusion