Analytical Sciences

Ascendia offers full analytical development services in support of our formulation development programs at both cGMP and non-GMP levels. We have capabilities in HPLC, UPLC, GC, LCMS, CAD, FTIR, Karl-Fischer, Differential Scanning Calorimetry (DSC) and Dissolution which allows us to have an in-depth understanding of our formulations. Using state-of-the-art equipment, and our expertise in analytical method development, we fully characterize the physical/chemical properties of both liquid and solid drug formulations, including forced degradation and impurity identification.

Depending on the formulation approach, different analytical techniques are used to characterize the formulation: assay; impurity identification and quantification; content uniformity determination via HPLC and UPLC (UV, PDA and CAD detectors); pH, density and viscosity testing; zeta potential and particle size determination (via laser diffraction or dynamic light scattering analysis) for nano-particles; solid state characterization via DVS, XRPD and DSC; in-vitro drug release via dissolution testing; and determination of physical tablet properties.
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