Registration Dossier

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): omeprazole chloremethylpyridine
- Substance type: organic
- Physical state: solid
- Analytical purity: 100 % (HPLC area percent)
- Purity test date: 20. 02. 2008
- Lot/batch No.: 30000859
- Expiration date of the lot/batch: 01. 2009

Results and discussion

Physical state at 20°C and 1013 hPa:
solid
Form / colour / odour
Form:
powder
Colour:
white or almost white crystaline powder
Odour:
other: strong, offensive odour
Substance type:
organic

Applicant's summary and conclusion