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Solid Form Changes That Reduce Solubility: Drug Substance and Formulation Risks in Drug Development
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Comprehensive stability and solubility studies are essential for understanding how an API behaves under real-world pharmaceutical development conditions. At Crystal Pharmatech, we evaluate both chemical and solid-state stability as well as solution behavior to identify risks such as form changes, amorphous crystallization, salt deliquescence, and degradation pathways.
By systematically probing these vulnerabilities, our studies help define the conditions that may impact formulation, manufacturing, and long-term product stability.
Our stability studies evaluate the chemical and physical resilience of APIs under conditions relevant to pharmaceutical development and ICH stability guidelines.
Stress testing under acid, base, hydrolysis, oxidation, elevated temperature, and light exposure to identify degradation pathways.
Assessment of polymorphic stability and physical form integrity across temperature and humidity conditions.
Targeted stability testing across controlled temperature and humidity profiles to determine degradation susceptibility.
Reliable solubility data are essential for predicting dose feasibility, supporting DCS classification, and guiding early formulation strategy. Our solubility studies evaluate both equilibrium and dynamic behaviors across physiologically relevant environments.
Determination of both transient and equilibrium solubility behavior.
Evaluation of solubility across physiological pH ranges to support formulation and absorption predictions.
Solubility measurements in simulated intestinal and gastric fluids including FaSSGF, FaSSIF, and FeSSIF.
Have a question or need support with your project? Please complete the form, and our team will get back to you shortly.
Our capabilities span three specialized platforms:
Small Molecule
Crystal Bio Solutions
Crystal NAX
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