Stress testing can reveal differences in the physical and chemical stabilities of various solid forms. Modes or rates of degradation can often be associated with particular solid forms such as polymorphs or solvates, since certain lattice types and modifications are more prone to degradation than others. We conduct high-temperature, high-humidity, and light-exposure degradation studies to identify and quantitate physical and chemical changes (XRPD and HPLC, respectively).
Our cGMP degradation studies can determine both the chemical stability and the solid-state stability of your drug substance, drug product, or chemical.
Dissolution rates often vary considerably with solid form. Dissolution tests are often used to ensure that production processes are under control. We determine dissolution rates and equilibrium solubilities using intrinsic and non-intrinsic methods.