Registration Dossier
Registration Dossier
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EC number: 813-788-3 | CAS number: 1803551-73-6
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:
- 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
- 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.
Reference
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.
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
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