Registration Dossier
Registration Dossier
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EC number: 617-191-7 | CAS number: 81060-07-3
Water solubility
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:
- 2 003
- 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
- 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.
Constituent 1
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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