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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Solubility of the test substance was demonstrated at different concentrations in DMSO. The highest measured concentration solution was stored for approximately 19 hours at room temperature. Following the 19 hour’s storage period the sample was reanalyzed by analytical methods to determine if degradation had occurred. The concentration of the sample was determined by the comparison against an external calibration curve.
GLP compliance:
yes
Test substance stable:
yes
Transformation products:
no
Conclusions:
Stability was demonstrated to be 100% of the original concentration at 504 mg/mL level for 19 hours at room temperature.
Executive summary:

The study was conducted to demonstrate sample stability up to and including 500 mg/mL in a solvent for future toxicological testing. The test substance is a medium yellow solid composed of one active compound. Solubility of the test substance was demonstrated at a concentration of 1.0, 50, and 504 mg/mL in DMSO. The 504 mg/mL solution was stored for approximately 19 hours at room temperature. Following the 19 hours storage period the sample was reanalyzed by LC/UV to determine if degradation had occurred. The concentration was determined to be 100% of the original concentration following storage for 19 hours at room temperature. The concentration of the sample was determined by the comparison against an external calibration curve.

Description of key information

Solubility of the test substance was demonstrated at different concentrations in DMSO.

Additional information

Stability was demonstrated to be 100% of the original concentration at 504 mg/mL level for 19 hours at room temperature. Stability was demonstrated to be 99% of the original concentration at 508 mg/mL level for 19 hours at room temperature.