Development and Validation of a HPLC-UV Method for Urea and Related Impurities

References

1. 1.↵
   1. Breslow R.,
   2. Guo T.

   Surface Tension Measurements Show That Chaotropic Salting-in Denaturants Are Not Just Water-Structure Breakers. Proc. Natl. Acad. Sci. U.S.A. 1990, 87 (1), 167–169.

   OpenUrlAbstract/FREE Full Text
2. 2.↵
   1. Marston F. A.

   The Purification of Eukaryotic Polypeptides Synthesized in Escherichia coli. Biochem. J. 1986, 240 (1), 1–12.

   OpenUrlFREE Full Text
3. 3.↵
   1. Setlow J. K.

   1. Kelley R. F.,
   2. Winkler M. E.

   Folding of Eukaryotic Proteins Produced in Escherichia coli. In Genetic Engineering: Principles and Methods, Vol 12; Setlow J. K., Ed.; Springer: Boston, MA, 1990; pp 1–19.

   OpenUrl
4. 4.↵
   1. Yamaguchi H.,
   2. Miyazaki M.

   Refolding Techniques for Recovering Biologically Active Recombinant Proteins from Inclusion Bodies. Biomolecules 2014, 4 (1), 235–251.

   OpenUrl
5. 5.↵
   1. Clark E. D. B.

   Protein Refolding for Industrial Processes. Curr. Opin. Biotechnol. 2001, 12 (2), 202–207.

   OpenUrlCrossRefPubMedWeb of Science
6. 6.↵
   1. Yan Z.,
   2. Huang J.

   Cleaning Procedure for Protein G Affinity Columns. J. Immunol. Methods 2000, 237 (1–2), 203–205.

   OpenUrlPubMed
7. 7.↵
   1. Bill E.,
   2. Lutz U.,
   3. Karlsson B.-M.,
   4. Sparrman M.,
   5. Allgaier H.

   Optimization of Protein G Chromatography for Biopharmaceutical Monoclonal Antibodies. J. Mol. Recognit. 1995, 8 (1–2), 90–94.

   OpenUrlPubMed
8. 8.↵
   1. Zhang J.,
   2. Siva S.,
   3. Caple R.,
   4. Ghose S.,
   5. Gronke R.

   Maximizing the Functional Lifetime of Protein a Resins. Biotechnol. Prog. 2017, 33 (3), 708–715.

   OpenUrl
9. 9.↵
   1. Choe W.,
   2. Durgannavar T. A.,
   3. Chung S. J.

   Fc-Binding Ligands of Immunoglobulin G: An Overview of High Affinity Proteins and Peptides. Materials (Basel) 2016, 9 (12), 994.

   OpenUrl
10. 10.↵
    1. Pathak M.,
    2. Ma G.,
    3. Bracewell D. G.,
    4. Rathore A. S.

    Re-Use of Protein A Resin: Fouling and Economics. BioPharm Int. 2015, 28 (3).
11. 11.↵
    1. Schiel J. E.,
    2. Davis D. L.,
    3. Borisov O. V.

    1. Prakash K.,
    2. Chen W.

    Analytical Methods for the Measurement of Host Cell Proteins and Other Process-Related Impurities. In State-of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization: The NISTmAb Case Study; Schiel J. E., Davis D. L., Borisov O. V., Eds.; ACS Symposium Series 1201; American Chemical Society: Washington, DC, 2015; pp 387–404.
12. 12.↵
    1. Redemann C. E.,
    2. Riesenfeld F. C.,
    3. Viola F. S. L.

    Formation of Biuret from Urea. Ind. Eng. Chem. 1958, 50 (4), 633–636.

    OpenUrlCrossRef
13. 13.↵
    U.S. Pharmacopeial Convention. USP Monograph: Urea. In USP 42-NF 37, USP: Rockville, Md., 2019; p 4515.
14. 14.↵
    1. Taylor A. J,
    2. Vadgama P.

    Analytical Reviews in Clinical Biochemistry: The Estimation of Urea. Ann. Clin. Biochem. 1992, 29 (3), 245–264.

    OpenUrlCrossRef
15. 15.↵
    1. Wilson B. W.

    Automatic Estimation of Urea Using Urease and Alkaline Phenol. Clin. Chem. 1966, 12 (6), 360–368.

    OpenUrlPubMed
16. 16.↵
    1. Pibarot P.,
    2. Pilard S.

    Analysis of Urea in Petfood Matrices: Comparison of Spectro-Colorimetric, Enzymatic and Liquid Chromatography Electrospray Ionization High Resolution Mass Spectrometry Methods. Am. J. Anal. Chem. 2012, 3 (9), 613–621.

    OpenUrl
17. 17.↵
    1. Rahmatullah M.,
    2. Boyde T. R. C.

    Improvements in the Determination of Urea Using Diacetyl Monoxime; Methods with and without Deproteinisation. Clin. Chim. Acta 1980, 107 (1–2), 3–9.

    OpenUrlCrossRefPubMedWeb of Science
18. 18.↵
    1. Knorst M. T.,
    2. Neubert R.,
    3. Wohlrab W.

    Analytical Methods for Measuring Urea in Pharmaceutical Formulations. J. Pharm. Biomed. Anal. 1997, 15 (11), 1627–1632.

    OpenUrlCrossRefPubMed
19. 19.↵
    1. Wheatley V. R.

    An Improved Diacetyl Reaction for the Estimation of Urea in Blood. Biochem. J. 1948, 43 (3), 420–422.

    OpenUrlFREE Full Text
20. 20.↵
    1. Dallet P.,
    2. Labat L.,
    3. Kummer E.,
    4. Dubost J. P.

    Determination of Urea, Allantoin and Lysine Pyroglutamate in Cosmetic Samples by Hydrophilic Interaction Chromatography. J. Chromatogr. B: Biomed. Sci. Appl. 2000, 742 (2), 447–452.

    OpenUrlPubMed
21. 21.↵
    1. Yassine M. M.,
    2. Dabek-Zlotorzynska E.,
    3. Celo V.

    Development of a Hydrophilic Interaction Liquid Chromatography-Mass Spectrometry Method for Detection and Quantification of Urea Thermal Decomposition by-Products in Emission from Diesel Engine Employing Selective Catalytic Reduction Technology. J. Chromatogr. A 2012, 1229, 208–215.

    OpenUrlCrossRefPubMed
22. 22.↵
    International Conference for Harmonisation. Quality Guideline Q2(R1): Validation of Analytical Procedures: Text and Methodology; ICH: Geneva, 1995.