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Stability in organic solvents and identity of relevant degradation products

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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:
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

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

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:
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

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

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.

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