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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
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:
N-(2-hydroxyethyl)phthalimide
EC Number:
223-434-4
EC Name:
N-(2-hydroxyethyl)phthalimide
Cas Number:
3891-07-4
Molecular formula:
C10H9NO3
IUPAC Name:
2-(2-hydroxyethyl)-2,3-dihydro-1H-isoindole-1,3-dione
Test material form:
solid: particulate/powder
Details on test material:
Test item: N-(2-HYDROXYETHYL) PHTHALIMIDE
CAS No.: 3891-07-4
Physical state: solid, powder
Colour and Odour: white, odourless
Active Ingredient Content (TLC): 98.95 %
Storage: on dry place, protected from light, 15-30 °C

Results and discussion

Remarks on result:
not determinable
Particle sizeopen allclose all
Percentile:
D10
Mean:
< 43 µm
St. dev.:
0
Percentile:
D50
Mean:
< 107 µm
St. dev.:
0
Percentile:
D90
Mean:
< 261 µm
St. dev.:
0
Particle size distribution at different passages
Remarks on result:
not measured/tested

Applicant's summary and conclusion