(-)-1β-2(2´-Diethoxy-carbonyl-ethyl)-1α-ethyl-1,2,3,4,6,7,12,12b-α-octahydro-indolo[2,3-a]quinolizin

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

Test material information

Constituent 1

Reference substance name:

(-)-1β-2(2´-Diethoxy-carbonyl-ethyl)-1α-ethyl-1,2,3,4,6,7,12,12b-α-octahydro-indolo[2,3-a]quinolizin

EC Number:

603-912-2

Cas Number:

135266-72-7

Molecular formula:

C25H34N2O4

IUPAC Name:

(-)-1β-2(2´-Diethoxy-carbonyl-ethyl)-1α-ethyl-1,2,3,4,6,7,12,12b-α-octahydro-indolo[2,3-a]quinolizin

Results and discussion

Remarks on result:

not determinable

Particle size

Particle size 1

Percentile:

D10

Mean:

<= 142 µm

St. dev.:

0

Particle size 2

Percentile:

D50

Mean:

<= 245 µm

St. dev.:

0

Particle size 3

Percentile:

D90

Mean:

<= 602 µm

St. dev.:

0

Particle size distribution at different passages

Remarks on result:

not measured/tested