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Physical & Chemical properties

Stability in organic solvents and identity of relevant degradation products

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Reference
Endpoint:
stability in organic solvents and identity of relevant degradation products
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016 - 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Principles of method if other than guideline:
The test item concentration in the test samples was determined by high performance liquid chromatography -mass spectrometry (HPLC-MS) using an external standard technique. The test item gave a chromatographic profile consisting of a single peak.
A method of analysis was developed and validated with respect to linearity, accuracy/precision and specificity. Stability and homogeneity was also performed on the formulations in ethanol at concentrations of 0.3 mg/mL and 100 mg/mL.
GLP compliance:
yes
Specific details on test material used for the study:
Storage/Usage Conditions: At room temperature. Store under inert gas. Protect from moisture
Test substance stable:
yes
Transformation products:
no

The test item was found to be stable at 4 and 24 hours when stored at room temperature in the light.

In conclusion, the results indicate the accurate use of the test item and ethanol as a vehicle during this study.

The formulations were found to be homogeneously prepared and sufficient formulation stability under storage conditions was proven.

Conclusions:
The results indicate the accurate use of the test item and ethanol as a vehicle during this study. The formulations were found to be homogeneously prepared and sufficient formulation stability under storage conditions at 4 and 24 hours
Executive summary:

A method of analysis was developed and validated with respect to linearity, accuracy/precision and specificity. Stability and homogeneity was performed on the formulations in ethanol at concentrations of 0.3 mg/mL and 100 mg/mL.

The results indicate the accurate use of the test item, RFR 6634 and ethanol as a vehicle during this study.

The formulations were found to be homogeneously prepared and sufficient formulation stability under storage conditions at 4 and 24 hours was proven,

when stored at room temperature in the light. The formulations were also found to be homogeneously prepared.

Description of key information

A method of analysis was developed and validated with respect to linearity, accuracy/precision and specificity. Stability and homogeneity was performed on the formulations in ethanol at concentrations of 0.3 mg/mL and 100 mg/mL.

The results indicate the accurate use of the test item, RFR 6634 and ethanol as a vehicle during this study.

The formulations were found to be homogeneously prepared and sufficient formulation stability under storage conditions at 4 and 24 hours was proven,

when stored at room temperature in the light. The formulations were also found to be homogeneously prepared.

Additional information