Registration Dossier
Registration Dossier
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EC number: 619-692-6 | CAS number: 156366-26-6
Solubility in organic solvents / fat solubility
Administrative data
- Endpoint:
- solubility in organic solvents / fat 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
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
Solubility in organic solvents / fat solubilityopen allclose all
- Medium:
- acetonitrile
- Solubility:
- > 0.1 - < 1 g/L
- Temp.:
- 22 °C
- Medium:
- methanol
- Solubility:
- > 10 - < 33.3 g/L
- Temp.:
- 22 °C
- Details on results:
- The result in the COA is written according to the EUR Pharmacopeia, General Notices and is equal to the numeric result written in this section.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
