Increasing the Robustness of Biopharmaceutical Precipitation Assays - Part I: Derivative UV Spectrophotometric Method Development for in-line Measurements.

In vitro precipitation assays are often applied to support drug and formulation development. Current methods applied to quantify the amount of dissolved drug, in particular (U)HPLC, require time-consuming sample preparation. Furthermore, small precipitates formed during the nucleation phase may not be removed quantitatively by filtration or centrifugation of the sample.