Solubility and Solution Behavior Analysis

Solubility and Solution Behavior Analysis is a comprehensive suite of advanced physicochemical tests designed to evaluate how drug substances interact with solvents under various environmental conditions. At STEMart, we provide end-to-end solutions to assess critical parameters such as maximum solubility, pH dependency, ionic strength effects, and solution turbidity. These analyses are essential for optimizing formulation development, enhancing bioavailability, and ensuring regulatory compliance. Our services address the challenges of poorly soluble drugs and help prevent issues like precipitation, aggregation, or phase separation in liquid formulations, ensuring stability throughout the product lifecycle. By integrating cutting-edge instrumentation, validated methodologies, and regulatory expertise, we support drug development from preclinical stages through to commercialization.

Our Solubility and Solution Behavior Analysis Services

Illusrtration of our solubility and solution behavior analysis services (STEart Original)

Maximum Solubility Determination

Quantifies the saturation concentration of a drug in a specific solvent under equilibrium conditions. Using shake-flask methods, HPLC, and advanced techniques like isothermal titration calorimetry (ITC), we determine intrinsic solubility to guide solvent selection, salt formation, and formulation design. Critical for BCS classification and bioavailability prediction.

pH-Dependent Solubility Analysis

Evaluates how solubility varies across physiologically relevant pH ranges (e.g., pH 1.2–7.4). By combining potentiometric titration and biorelevant media testing, we identify optimal pH conditions for dissolution and assess risks of pH-triggered precipitation. Essential for oral dosage forms and ionizable drugs.

Ionic Strength Dependency Analysis

Measures the impact of salt concentration on drug solubility and colloidal stability. Using Debye-Hückel theory and dynamic light scattering (DLS), we predict salting-in/salting-out effects and optimize formulations for compatibility with physiological fluids (e.g., saline infusions).

Solution Turbidity Measurement

Quantifies cloudiness caused by suspended particles to assess physical stability. Via nephelometry, DLS, and microscopy, we detect subvisible particles, monitor aggregation, and ensure compliance with USP <788> particulate limits for injectables and ophthalmics.

Partner With Us

Unmatched Expertise: Experience in solubility profiling for small molecules, biologics, and advanced therapies, with expertise in regulatory guidelines to expedite submissions.
Advanced Technology: Cutting-edge instruments and automated systems for high-throughput screening, ensuring precise and rapid testing.
End-to-End Solutions: Comprehensive support from discovery to commercialization with customized protocols for novel drug formulations.
Global Compliance: Audit-ready, ICH Q2(R1)-validated data packages and regulatory expertise for seamless FDA/EMA engagement.
Collaborative Partnership: PhD-level scientists for method development and quick turnaround on critical-path projects.

For more information on our Solubility and Solution Behavior Analysis services or to discuss your specific requirements, please contact us today.