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

1
Chemical structure
Reference substance name:
(-)-1-Benzyl-4-(-4-fluor-phenyl)-3-hydroxymethyl-1,2,3,6-tetrahydropyridine-L-dibenzoyl-tartaric salt
EC Number:
606-459-9
Cas Number:
201855-57-4
Molecular formula:
C37H34FNO9
IUPAC Name:
(-)-1-Benzyl-4-(-4-fluor-phenyl)-3-hydroxymethyl-1,2,3,6-tetrahydropyridine-L-dibenzoyl-tartaric salt
Test material form:
solid: crystalline
Specific details on test material used for the study:
Batch number: L63046N

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 almost white or yellow.)
Substance type:
organic

Applicant's summary and conclusion