Purity profiling of Peptide Drugs

Abstract

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.

Recent Advances of Nanocarriers for Effective Delivery of Therapeutic Peptides

“…Peptide-related impurities including degraded products and residual solvents, must be precisely controlled during peptide drug production based on the guidelines. The proposed threshold of these impurities usually depends on the type of clinical application (e.g., therapeutic, vaccine, diagnostic) of the peptide 18 .…”

Development and validation of a micellar electrokinetic capillary chromatography method for the determination of goserelin and related substances

“…An increasing variety of peptides has been produced, and these compounds have been approved as therapeutic agents to treat diseases, such as cancer, autoimmune diseases, and diabetes [1,2]. Goserelin is a synthetic decapeptide analog of luteinizing hormone-releasing hormone, which is used for the palliative treatment of advanced prostatic carcinoma, breast cancers, and several benign gynecological disorders, such as endometriosis and uterine fibroids [3,4].…”