Registration Dossier
Registration Dossier
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EC number: 485-140-4 | CAS number: 515815-48-2
Partition coefficient
Administrative data
- Endpoint:
- partition coefficient
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 29 October 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and in accordance with internationally established guidelines (OECD, EEC, see below). BIBR 277 CL is the hydrochloride of Telmisartan (free acid).
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 117 (Partition Coefficient (n-octanol / water), HPLC Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of method:
- HPLC method
- Partition coefficient type:
- octanol-water
Test material
- Reference substance name:
- 144701-48-4
- Cas Number:
- 144701-48-4
- IUPAC Name:
- 144701-48-4
- Reference substance name:
- Telmisartan
- IUPAC Name:
- Telmisartan
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): Telmisartan
- Molecular formula (if other than submission substance): C33H30N4O2
- Structural formula attached as image file (if other than submission substance): see attached report
- Physical state: solid
- Analytical purity: 99.9%
- Lot/batch No.: 1007523
- Expiration date of the lot/batch: September 2005
- Stability under test conditions: yes, analytical monitoring in place
- Storage condition of test material: at room temperature, dry, in the dark.
Constituent 1
Constituent 2
Study design
- Analytical method:
- high-performance liquid chromatography
Results and discussion
Partition coefficient
- Type:
- log Pow
- Partition coefficient:
- 3.5
- Temp.:
- 25 °C
- pH:
- 4.3
Applicant's summary and conclusion
- Conclusions:
- In this study, the log Pow of Telmisartan was calculated to be 3.5 at 25°C and pH 4.3.
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