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EC number: 918-919-9 | CAS number: -
Stability in organic solvents and identity of relevant degradation products
Administrative data
Link to relevant study record(s)
- Endpoint:
- stability in organic solvents and identity of relevant degradation products
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-10-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- other: SOP 00191
- Version / remarks:
- Version 2
- Deviations:
- no
- Principles of method if other than guideline:
- - The content of the active substances was not considered for preparation of formulations.
- For 1 mg/mL: Approx. 200 mg of the test item were dissolved and homogenized in 20 mL with acetone / olive oil (4+1) by manual shaking.
- For 500 mg/mL: Approx. 10000 mg of the test item were dissolved and homogenized in 20 mL with acetone / olive oil (4+1) by manual shaking.
Analysis via HPLC-UV - GLP compliance:
- yes
- Specific details on test material used for the study:
- Expiry date: 2016-07-01
- Test substance stable:
- yes
- Remarks:
- Test item is stable for at least 4 days in the refrigerator in acetone / olive oil (4+1).
- Transformation products:
- no
- Conclusions:
- Test item phosphorothioyltris(oxybenzene-4,1-diylcarbamoyloxyethane- 2,1-diyl) trisprop-2-enoate is stable in acetone / olive oil (4+1) for at least 4 days in the refrigerator.
- Executive summary:
According to SOP 00191 Version 2, the 1 mg/mL and 500 mg/mL formulations of the test item, phosphorothioyltris(oxybenzene-4,1-diylcarbamoyloxyethane-2,1-diyl) trisprop-2-enoate, in acetone / olive oil (4 +1) are homogenous and stable for at least 4 days in the refrigerator.
- Endpoint:
- stability in organic solvents and identity of relevant degradation products
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-10-16
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- other: SOP 00191
- Version / remarks:
- Version 2
- Deviations:
- no
- Principles of method if other than guideline:
- For 5 mg/mL: Approx. 240 mg of the test item were dissolved and homogenized in 20 mL with PEG 400 by manual shaking.
For 200 mg/mL: Approx. 4800 mg of the test item were dissolved and homogenized in 10 mL with PEG 400 by manual shaking.
Analysis via HPLC-UV - GLP compliance:
- yes
- Specific details on test material used for the study:
- Expiry date: 2016-07-01
- Test substance stable:
- yes
- Remarks:
- Test item is stable for at least 2 days at room temperature in PEG 400.
- Transformation products:
- no
- Conclusions:
- Test item phosphorothioyltris(oxybenzene-4,1-diylcarbamoyloxyethane- 2,1-diyl) trisprop-2-enoate is stable in PEG 400 for at least 2 days at room temperature.
- Executive summary:
According to SOP 00191 Version 2, the 5 mg/mL and 200 mg/mL formulations of the test item, phosphorothioyltris(oxybenzene-4,1-diylcarbamoyloxyethane-2,1-diyl) trisprop-2-enoate, in PEG 400 are homogenous and stable for at least 2 days at room temperature.
Referenceopen allclose all
The stability of the test item was determined based on the monitoring of the main peak present in the HPLC-UV chromatogram of the test item.
| Nominal value | Theoretical value | Content Test Item [mg/mL]* | Recovery as % of theoretical value | ||||
| [mg/mL] | [mg/mL] | Start | After 2 hours | After 4 days | Start | After 2 hours | After 4 days |
| 1 | 9.65 | 9.67 | 9.74 | 9.74 | 100 | 101 | 101 |
| 500 | 500.94 | 517.64 | 512.01 | 517.21 | 103 | 102 | 103 |
* mean values of two replicates
The stability of the test item was determined based on the monitoring of the main peak present in the HPLC-UV chromatogram of the test item.
| Nominal value | Theoretical value | Content Test Item [mg/mL] | Recovery as % of theoretical value | ||
| [mg/mL]* | [mg/mL]* | Start | After 2 days | Start | After 2 days |
| 5 | 4.967 | 5.162 | 4.418 | 104 | 89 |
| 200 | 202.750 | 214.165 | 205.315 | 106 | 101 |
* mean values of two replicates
Description of key information
Test item phosphorothioyltris(oxybenzene-4,1-diylcarbamoyloxyethane-2,1-diyl) trisprop-2-enoate is stable in PEG 400 for at least 2 days at room temperature and in acetone / olive oil (4:1) for at least 4 days in the refrigerator.
Additional information
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