Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: PhEUR, General Notices.
Deviations:
no
Type of method:
flask method

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: 02. 2008
- Lot/batch No.: 30000859
- Expiration date of the lot/batch: 01. 2009

Results and discussion

Water solubility
Water solubility:
> 1 000 g/L
Temp.:
22 °C
Details on results:
Very soluble mean solubility greater than 1000 g/l according to Pharmacopeia, General Notices.

Any other information on results incl. tables

The result in the COA is written according to the Pharmacopeia and is equal to the numeric result written in this section.

Applicant's summary and conclusion