Dose Formulation Analysis is an essential step in regulated nonclinical studies. Robust analytical methods, rapid turnaround, and efficient communication helps ensure the dose form results for your GLP studies are delivered on time.
At KCAS, our scientific expertise allows us to develop methods that achieve your study requirements. Our experts understand the different complexities involved in dose formulation vehicles as well as complex biological matrices. This means we develop validated methods quickly, using the appropriate analytical tools for your studies.
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 delivers high quality data on time to our customers, helping them in their drug development needs.
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.
Don’t let rework slow down your IND programs.
Partner with the KCAS team to manage your small and large molecule dose formulation analyses. Whether SEC, HPLC–UV or LC-MS, GLP or non
GLP, our expert team delivers validated dose formulation stability, homogeneity, purity, and content analyses.
Visit our facility and take your GLP dose formulation research to the next level.
If you have any questions about this or any other services from KCAS, we invite you to reach out using the form below!