Annex G. Solubility
How do we measure solubility? |
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How does insolubility affect the concentration in an in vitro method? |
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For some test items achieving suggested maximal target test concentration is difficult due to lack of solubility in test media. |
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For these test items should there be guidance on how to establish the top concentration to test? For example if guidance indicates substances should be tested at top concentration of 1 mg/mL or 1mM but a substance does not go into solution at that concentration, is there some fractional concentration factor that should be used to determine what next lower concentration to try? |
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If it is difficult to get a test item in solution, at what point is the test item set aside as non-testable in the in vitro method? |
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Is there a standard method or methods that could be used to accurately establish the solubility limits of test items so appropriate concentrations could be selected for testing? |
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Are there methods for determining solubility that work for some types of test items and not others? |
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What are the set of acceptable solvents that are compatible with in vitro assays? |
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If a test item is not soluble in the preferred solvent for a given in vitro method, how many of the other potential solvents should be tried? Will the compatible solvents be specific to each in vitro method and should the in vitro method define which are acceptable solvents and at what concentrations they are acceptable in the final test media? |
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If a substance is highly soluble in an aqueous solution, can the substance be dissolved in the in vitro method media directly and tested without solvent carrier? |
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