Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.6303 (Physical State)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Pseudoephedrine
EC Number:
202-018-6
EC Name:
Pseudoephedrine
Cas Number:
90-82-4
Molecular formula:
C10H15NO
IUPAC Name:
(1S,2S)-2-(methylamino)-1-phenylpropan-1-ol
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): ( + )-Pseudoephedrine
- Physical state: solid
- Analytical purity: 99.9 %
- Lot/batch No.: 023513AX20

Results and discussion

Physical state at 20°C and 1013 hPa:
solid
Form / colour / odour
Form:
crystalline

Applicant's summary and conclusion