Solubility – Shake Flask
This assay is used to determine the solubility of a test article at room temperature in aqueous buffer at pH 7.4.
Required from Sponsor
- A minimum of 10 mg of powder
- Exact molecular mass of test article and its salt form
- MSDS or handling and storage information, e.g., light sensitive, store at -20°C, etc.
- The solubility of the test article, in either mg/mL, µg/mL, or µM
- The test article dissolved in aqueous buffer, pH 7.4, at room temperature
- 1.5 mL shake flask
- Solubility range by this method of determination: 1.0 to 0.0002 mg/mL depending on analytical sensitivity
- This assay is run with a single replicate (n=1)
- Mix >1.0 mg of test article with 1.0 mL of aqueous buffer, pH 7.4
- Equilibrate overnight at room temperature (>16 hours), with shaking
- Filter the solution and sample the filtrate in duplicate (n=2)
- Determine the concentration of test article using a generic LC-MS/MS method with a minimum 6-point calibration curve
- The results from this assay are sent to the sponsor in the ExpressPlus report format, which may include graphical representations of data and comparison with historical data for reference articles.
- In this assay, it is not determined if a saturated solution is obtained. Thus, the value obtained might not be the true equilibrium solubility of the test article.
- In this assay, neither the recovery nor the stability of test article is determined.
- Unless told otherwise by the sponsor it is assumed that the test article is 100% pure.