PT  - JOURNAL ARTICLE
AU  - Getachew Woldemariam
AU  - Ali Kyad
AU  - Stephanie Moore
AU  - Jinshu Qiu
AU  - David Semin
AU  - Zhixin J. Tan
AU  - Jette Wypych
TI  - Development and Validation of a HPLC-UV Method for Urea and Related Impurities
AID  - 10.5731/pdajpst.2018.009803
DP  - 2020 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 2--14
VI  - 74
IP  - 1
4099  - http://journal.pda.org/content/74/1/2.short
4100  - http://journal.pda.org/content/74/1/2.full
SO  - PDA J Pharm Sci Technol2020 Jan 01; 74
AB  - 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.