Ascendia offers full analytical development services in support of formulation development programs both under cGMP and non-GMP conditions. We provide analytical methods development, validation and testing support using state-of-the-art equipment including HPLC, UPLC, GC, LCMS, FTIR, Karl-Fischer, Differential Scanning Calorimetry (DSC) and Dissolution which allows us to have an in-depth understanding of our formulations. The HPLC/UPLC detection systems include Photodiode Array (PDA), Charged Aerosol Detector (CAD, Corona Veo RS), and Refractive Index. Using these analytical instruments, 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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