Solid, semisolid, and liquid formulation of pharmaceuticals are a key step in the drug development and preclinical process. Methods are developed to confirm APIs in the dosing formulation, as well as formulation homogeneity, and stability. In addition, if stereoisomers are part of the formulation, regulatory agencies now require each enantiomer to be separated and studied individually.
KCAS has significant experience in all aspects of dose formulation analysis. Methods utilizing either UV/Vis or Fluorescence detectors, whichever is appropriate for your protein or small molecule. In addition, KCAS has substantial infrastructure and decades of expertise in qualitative and quantitative separations utilizing HPLC mass spectrometry detection of peptide drugs. Solid, semisolid, and liquid formulations of pharmaceutical leads are one key step in drug development.
Methods are optimized to confirm the API concentration in your dosing formulation, as well as solution uniformity, and stability. In addition, if stereoisomers are part of the formulation, we have years of chiral experience at your service.