RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 2
OP 14
DO 10.5731/pdajpst.2018.009803
VO 74
IS 1
A1 Getachew Woldemariam
A1 Ali Kyad
A1 Stephanie Moore
A1 Jinshu Qiu
A1 David Semin
A1 Zhixin J. Tan
A1 Jette Wypych
YR 2020
UL http://journal.pda.org/content/74/1/2.abstract
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.