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:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US PHARMACOPEIA 786, Ph.Eur 2.9.38
Deviations:
no
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

Results and discussion

Remarks on result:
not determinable
Particle sizeopen allclose all
Percentile:
D10
Mean:
< 152 µm
St. dev.:
0
Percentile:
D50
Mean:
< 261 µm
St. dev.:
0
Percentile:
D90
Mean:
< 463 µm
St. dev.:
0

Applicant's summary and conclusion