Registration Dossier
Registration Dossier
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EC number: 413-410-3 | CAS number: 88150-62-3 AMLODIPINE STEP 3; UK-52,416
Partition coefficient
Administrative data
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
- GLP compliance:
- no
- Type of method:
- HPLC method
- Partition coefficient type:
- octanol-water
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: crystalline
Constituent 1
Study design
- Analytical method:
- high-performance liquid chromatography
Results and discussion
Partition coefficient
- Key result
- Type:
- log Pow
- Partition coefficient:
- 4.9
- Temp.:
- 30 °C
- pH:
- 6.79
- Details on results:
- Determination of the partition coefficient of Amlodipine Phthaloyl (CAS No. 88150-62-3) was based on the measurement of retention time of the test and reference items by reverse phase HPLC method. The retention times of the test and reference items were determined in two replicates injecting twice both of them. The test item was dissolved in methanol, then diluted in methanol/ultrapure water (70:30) to obtain a final concentration of 100 mg/l.
Applicant's summary and conclusion
- Conclusions:
- The value of partition coefficient of Amlodipine Phthaloyl (CAS No. 88150-62-3) was determined by Microsoft Office Excel 2013. The following value was calculated: logPow= 4.9
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