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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17.02.2003 - 27.02.2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The Study was done in accordance with the Study Protocol CH - 25/2003 and the following guidelines: - OECD Guidelines for Testing Chemicals. Testing Guideline No. 105, Paris, 1981 - Official Journal ofthe European Communities No. L383/A, 29.12.92: Methods for the Determination of Physical-Chemical Properties : A.6 Water Solubility - Flask method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Remarks:
HPLC

Test material

Constituent 1
Reference substance name:
Bromohexine hydrobromide
IUPAC Name:
Bromohexine hydrobromide
Details on test material:
- Lot/batch No.: 02070864
- Storage condition of test material: stored at room temperature in the dark.

Results and discussion

Water solubility
Water solubility:
2.5 g/L
Temp.:
20 °C
pH:
4.5

Any other information on results incl. tables

The quality criteria of the A.6 method is verified (RDS% over three values is « 15%)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): soluble (1000-10000 mg/L)
From the experimental data obtained in the present study it is concluded that the water
solubility of the bromohexine hydrobromide sample is 2.53 g/L (2530 ppm) at 20 °C.

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