Registration Dossier
Registration Dossier
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EC number: 606-728-0 | CAS number: 212322-56-0
Partition coefficient
Administrative data
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 October 2017 to 19 October 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.8 (Partition Coefficient - HPLC Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- HPLC method
- Partition coefficient type:
- octanol-water
Test material
- Reference substance name:
- ethyl 3-{1-[3-amino-4-(methylamino)phenyl]-N-(pyridin-2-yl)formamido}propanoate
- EC Number:
- 606-728-0
- Cas Number:
- 212322-56-0
- Molecular formula:
- C18 H22 N4 O3
- IUPAC Name:
- ethyl 3-{1-[3-amino-4-(methylamino)phenyl]-N-(pyridin-2-yl)formamido}propanoate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Chemicals and Reagents used are Water (Ultra Pure-grade) and Methanol (LCMS grade).
Used the Agilent 1260 HPLC system with column Luna 5µ C18(2) 100 A; 250 x 3.0mm, Phenomenex
Methanol was used as diluent for the test item solution. Methanol was used for the reference item solution.
A sample was prepared containing 41.6 mg/L BIBR 1048 Diamine in diluent.
The reference mix was prepared in methanol.
Study design
- Analytical method:
- high-performance liquid chromatography
Results and discussion
Partition coefficient
- Key result
- Type:
- log Pow
- Partition coefficient:
- 1.37
- Temp.:
- 20 °C
- Remarks on result:
- other: None
Applicant's summary and conclusion
- Conclusions:
- The log Pow (n-octanol/water) of BIBR 1048 Diamine was determined by HPLC at 20 °C +/- 1 °C to be 1.37.
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