Registration Dossier
Registration Dossier
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EC number: 619-692-6 | CAS number: 156366-26-6
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: PhEUR, General Notices
- Deviations:
- no
- Type of method:
- flask method
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Amlodipine ETA
- Substance type: organic compound
- Isomers composition: No chiral centre in the molecule
- Physical state: very viscose red to brown coloured oil
- Analytical purity: 85%
- Storage condition of test material: room temperature
- Impurities (identity and concentrations): 2-triphenylmethylamino ethanole, 7,71 HPLC area percent,
- Purity test date: 04. 2008
- Lot/batch No.: 30007398
- Expiration date of the lot/batch: 10. 2008
Results and discussion
Water solubility
- Water solubility:
- < 0.1 g/L
- Temp.:
- 22 °C
- Details on results:
- The result in the COA is written according to the Pharmacopeia, General Notices and is equal to the numeric result written in this section.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: less than 0,1 g/L
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