Registration Dossier

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other: own company data
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Company Quality Test Specification
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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: L63095N

Results and discussion

Physical state at 20°C and 1013 hPa:
solid
Form / colour / odour
Form:
solid: particulate/powder
Colour:
almost white(According to Quality Test Specification it can be light almost white or yellow.)
Substance type:
organic

Applicant's summary and conclusion