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Physical & Chemical properties

Solubility in organic solvents / fat solubility

Administrative data

Endpoint:
solubility in organic solvents / fat 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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Omeprazole chloromethylpyridine
- 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

Solubility in organic solvents / fat solubilityopen allclose all
Medium:
ethanol
Solubility:
> 100 - < 1 000 g/L
Temp.:
22 °C
Medium:
methanol
Solubility:
> 100 - < 1 000 g/L
Temp.:
22 °C
Test substance stable:
not determined
Details on results:
Freely soluble mean solubility greater between 100 and 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