Solubility testing methods
- Saturation concentration measurement
This method is used to measure the solubility by adding the drug to the medium until it starts to precipitate and the concentration of the drug in the excipient is no longer increasing.
When using liquid lipid excipients, UPLC/HPLC can be used to determine the equilibrium solubility of the drug.
- Differential thermal scanning calorimetry (DSC) & hot stage microscopy (HSM) techniques
When semi-solid lipid excipients are used, differential scanning calorimetry (DSC) and/or hot bench microscopy (HSM) can be used for relevant measurements.
Solubility curve method development
Solubility curves are obtained by continuous dynamic method testing.
Assay Method Validation
In order to examine whether the analytical assay methods described above have excellent results for solubility and solubility curves, we performed method validation services. The method specificity, linearity, range, accuracy, repeatability and intermediate precision are evaluated to ensure the validity and reliability of the method.