Registration Dossier
Registration Dossier
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EC number: 225-690-2 | CAS number: 5011-34-7
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 sept 2017 to 15 oct 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
Test material
- Reference substance name:
- Trimetazidine
- EC Number:
- 225-690-2
- EC Name:
- Trimetazidine
- Cas Number:
- 5011-34-7
- Molecular formula:
- C14H22N2O3
- IUPAC Name:
- 1-[(2,3,4-trimethoxyphenyl)methyl]piperazine
- Test material form:
- liquid
- Details on test material:
- No details are provided in the study report
Constituent 1
- Specific details on test material used for the study:
- Batch: 18128536
Purity: 89.1%
Results and discussion
Water solubility
- Key result
- Water solubility:
- >= 304 g/L
- Conc. based on:
- test mat.
- Temp.:
- 20 °C
- pH:
- ca. 11.6
Applicant's summary and conclusion
- Conclusions:
- The water solubility of the test item has been determined to be greater than or equal to 304 g/L of solution at 20.0 ± 0.5 °C.
- Executive summary:
The general physico-chemical properties of TMZ Base have been determined. The results are summarized below:
Water Solubility. Greater than or equal to 304 g/L of solution at 20.0 ± 0.5 °C, using the flask method, designed to be compatible with Method A.6 Water Solubility of Commission
Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995.
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