TY - JOUR T1 - Development and Validation of a HPLC-UV Method for Urea and Related Impurities JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 2 LP - 14 DO - 10.5731/pdajpst.2018.009803 VL - 74 IS - 1 AU - Getachew Woldemariam AU - Ali Kyad AU - Stephanie Moore AU - Jinshu Qiu AU - David Semin AU - Zhixin J. Tan AU - Jette Wypych Y1 - 2020/01/01 UR - http://journal.pda.org/content/74/1/2.abstract N2 - Urea is used in biopharmaceutical manufacturing processes for the purification of therapeutic proteins, for cleaning columns, and for refolding proteins after purification. The urea used for such purposes is typically USP grade material obtained from commercial sources and further characterization is required prior to use, such as determination of purity and identity. For this purpose, a robust analytical method is needed that can characterize the known organic impurities of urea. However, the existing methods show high assay variability and are not able to resolve all known organic impurities as desired for accurate quantification. In the present manuscript we developed a new high-performance liquid chromatography method with UV detection for the separation of urea and its impurities (biuret, cyanuric acid, and triuret). The method performance characteristics evaluated for urea and biuret were specificity, linearity, accuracy, identity, precision, and robustness and the newly developed method met all predefined performance acceptance criteria. ER -