Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only result available.

Data source

Reference
Reference Type:
other: own company data
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
(4aR,4bS,6aS,9aS,9bR,11aR)-4a,6a-Dimethyltetradecahydro-1H-indeno[5,4-f]quinoline-2,7-dione
EC Number:
616-323-0
Cas Number:
76318-69-9
Molecular formula:
C18H27NO2
IUPAC Name:
(4aR,4bS,6aS,9aS,9bR,11aR)-4a,6a-Dimethyltetradecahydro-1H-indeno[5,4-f]quinoline-2,7-dione
Test material form:
solid: crystalline
Details on test material:
Test item: finasteride saturated lactam
Batch No.: M4A085N
Physical state: crystalline powder
Colour: almost white
Storage: at 15-30 °C, protected from light and wet

Results and discussion

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

Applicant's summary and conclusion