Dose Formulation Analysis: Accurate and On Time

Efficient Dose Formulation Analysis supports effective regulated preclinical milestones. Robust analytical methods, fast turnaround, and strong communication ensures the dose form results for your GLP studies are delivered on time. At KCAS, our scientific expertise allows us to develop methods that will meet the requirements for your study design. Our experts understand the different complexities involved in dosing formulation vehicles as well as complex biological matrices. This means we will develop a fit for purpose method, using the appropriate analytical tool for quantitation.

 

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 spectrometric 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 of the 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!