Solubility and chemical quantification of APIs / drugs
Quantification of API Concentration in Sample Solutions
We offer precise quantification of APIs in sample solutions sent to us. This service enables research groups and smaller companies to conduct studies on delivered dose and cascade impactor without needing in-house HPLC capabilities. Our extensive library of ready-to-use assay methods is available—please contact us to verify which APIs we can quantify. Additionally, we provide guidance on preparing your vials and can assist in calculating all vital impactor output parameters, such as fine particle fraction (FPF), mass median aerodynamic diameter (MMAD), and geometric standard deviation (GSD).
API Solubility in Different Conditions and Kinetic Solubility
Beyond assay quantification of solubilized substances in vials, we determine the solubility of APIs in various solvent media (different pHs and surfactants) at body-relevant temperatures. This data is crucial for dissolution and physiologically based biopharmaceutics (PBB) modeling to predict systemic exposure after lung deposition. We also perform kinetic solubility measurements, determining solubilized API over time. The solubility measurements are performed according to USP <1236>, based on the shake-flask method.
Our laboratory services are powered by HPLC (High-Performance Liquid Chromatography) instruments, utilizing both Agilent and Thermo Fisher (Vanquish) systems, with Chromeleon as our Chromatography Data System (CDS).
Solubility and chemical quantification of APIs/drugs at Emmace Lab by Lena Heinz Wannerberg.
