Purity profiling of Peptide Drugs
Sylvia Van Dorpe, Mathieu Verbeken, Evelien Wynendaele and Bart De Spiegeleer*
Drug Quality and Registration (DruQuaR) group, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium
- *Corresponding Author:
- Bart De Spiegeleer
Drug Quality and Registration (DruQuaR) group
Faculty of Pharmaceutical Sciences, Ghent University
Harelbekestraat 72, B-9000 Ghent, Belgium
Tel: +32 9 264 8100
Fax: +32 9 264 8193
E-mail: [email protected]
Received Date: October 22, 2011; Accepted Date: November 10, 2011; Published Date: November 12, 2011
Citation:Van Dorpe S, Verbeken M, Wynendaele E, De Spiegeleer B (2011) Purity Profiling of Peptide Drugs. J Bioanal Biomed S6: 003. doi:10.4172/1948-593X.S6-003
Copyright: © 2011 Van Dorpe S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
The quality of a peptide drug mainly depends on its impurity profile, with the emphasis on the related impurities. These impurities may be biomedically active, alter the desired efficacy or induce unwanted toxicity, an aspect which is termed the “functional quality” of the peptide drug. Therefore, regulatory authorities have set up guidances or have legally established specification limits to assure a consistent purity of these peptide drugs. For the active pharmaceutical ingredients (APIs), the pharmacopoeial monographs are legally binding. Additional information can be found in regional and international guidelines. For the finished pharmaceutical drug products (FDPs) containing peptide active ingredients, only general guidelines are available. The construction of a complete related-impurity profile is very challenging due to the wide availability of different protecting groups, coupling agents and additives that may be used during peptide synthesis. In addition, chemical degradation, occurring during synthesis, formulation or at storage, may occur as well, including not only so-called pure chemical degradation but interaction with excipients as well. This review provides an update of the regulatory and scientific rationales behind the related impurities in peptide drugs.