Solid, semisolid, and liquid formulation of pharmaceuticals are a key step in the drug development and marketing process. Methods are developed to confirm the concentration of APIs in the dosing formulation, as well as the formulation uniformity, and stability. In addition, if stereoisomers are part of the formulation, regulatory agencies now require individual enantiomers to be separated and studied separately.
KCAS has a significant experience in all aspects of dose formulation analysis. Methods utilize either UV/Vis or Fluorescence detectors, whichever is appropriate. In addition, KCAS has substantial infrastructure and decades of expertise in qualitative and quantitative chiral separation utilizing UV/Vis, Fluorescence or mass spectrometer detection.
At KCAS, the scientific expertise allows us to develop methods that will meet the requirements of the study design. Our experts understand the different complexities involved in dosing formulation vehicles as compared to complex biological matrices. This background ensures we develop a fit for purpose method, using the appropriate analytical tool for quantitation. KCAS delivers high quality data on time to our customers, to help them in their drug development needs.