Registration Dossier
Registration Dossier
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EC number: 413-410-3 | CAS number: 88150-62-3 AMLODIPINE STEP 3; UK-52,416
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study according to international accepted guidelines (slightly modified) but not GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- slightly modified
- GLP compliance:
- no
- Type of method:
- flask method
Test material
- Reference substance name:
- 3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate
- EC Number:
- 413-410-3
- EC Name:
- 3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate
- Cas Number:
- 88150-62-3
- Molecular formula:
- C28H27ClN2O7
- IUPAC Name:
- 3-ethyl 5-methyl 4-(2-chlorophenyl)-2-{[2-(1,3-dioxo-2,3-dihydro-1H-isoindol-2-yl)ethoxy]methyl}-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test item: Amlodipine phthaloyl
CAS: 88150-62-3
Physical state: solid, crystalline powder
Colour: light-yellowish-white
Storage: at a temperature of 15 to 30 °C
Constituent 1
Results and discussion
Water solubility
- Water solubility:
- 0.017 g/L
- Temp.:
- 20 °C
- pH:
- ca. 7.18
- Remarks on result:
- other: +/-0.001 g/L
- Details on results:
- Water solubility from the preliminary test: < 1 g/L.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): slightly soluble (0.1-100 mg/L)
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