Butanedioic acid, 2,3-bis(benzoyloxy)-, (2R,3R)-, compd. with (3R,4R)-4-(4-fluorophenyl)-1-(phenylmethyl)-3-piperidinemethanol (1:1)

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:

(-)-3R,4R-1-Benzyl-4-(4-fluorophenyl)-3-hydroxymethyl-piperide-L-dibenzoyl tartrate

EC Number:

606-460-4

Cas Number:

201855-65-4

Molecular formula:

C19H22FNO + C18H14O8 = C37H36FNO9

IUPAC Name:

(-)-3R,4R-1-Benzyl-4-(4-fluorophenyl)-3-hydroxymethyl-piperide-L-dibenzoyl tartrate

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Batch number: L63095NStorage conditions: 15-30 °C

Results and discussion

Remarks on result:

not measured/tested

Particle size

Particle size 1

Percentile:

D10

Mean:

< 0.181 mm

St. dev.:

0

Particle size 2

Percentile:

D50

Mean:

< 0.295 mm

St. dev.:

0

Particle size 3

Percentile:

D90

Mean:

< 0.456 mm

St. dev.:

0

Particle size distribution at different passages

Remarks on result:

not measured/tested