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:
other: US PHARMACOPEIA 786, Ph.Eur 2.9.38
GLP compliance:
no
Type of method:
sieving
Type of distribution:
mass based distribution

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Test item: estradiol-methyl-ether-acetateCAS No.: 5976-55-6Physical state: white crystalline powderStorage:15-30 °C, protected from light and wet

Results and discussion

Particle sizeopen allclose all
Percentile:
D10
Mean:
< 0.227 mm
St. dev.:
0
Percentile:
D50
Mean:
< 0.451 mm
St. dev.:
0
Percentile:
D90
Mean:
< 0.719 mm
St. dev.:
0
Particle size distribution at different passages
Remarks on result:
not determinable

Applicant's summary and conclusion