INSTITUTIONAL DIGITAL REPOSITORY

Synthesis and characterization of two potential impurities (desethyl-Ganirelix) generated in the Ganirelix manufacturing process

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dc.contributor.author Chatterjee, S.
dc.contributor.author Bandyopadhyay, A.
dc.date.accessioned 2024-06-20T13:04:51Z
dc.date.available 2024-06-20T13:04:51Z
dc.date.issued 2024-06-20
dc.identifier.uri http://dspace.iitrpr.ac.in:8080/xmlui/handle/123456789/4611
dc.description.abstract Controlling certain diseases using peptide drugs has remarkably increased in the past two decades. In this regard, a generic formulation is an upfront solution to fulfill market demands. Ganirelix, a leading peptide active pharmaceutical ingredient (API) primarily used as a gonadotropin-releasing hormone antagonist (GnRH), has established a potential market value worldwide. But its generic formulation mandates detailed impurity profiles from a synthetic source and contemplates the sameness of a reference-listed drug (RLD). Post-chemical synthesis and processing of Ganirelix, some commercial sources have revealed two new potential impurities among many known, which show the deletion of an ethyl group from the hArg(Et)2 residue at the sixth and eighth positions, named des-ethyl-Ganirelix. These impurities are unprecedented in traditional peptide chemistry, and such monoethylated-hArg building blocks are not easily accessible commercially to synthesize these two impurities. Here, we have outlined the synthesis, purification, and enantiomeric purity characterization of the amino acids and their incorporation in the Ganirelix peptide sequence to synthesize these potential peptide impurities. This methodology will enable the convenient synthesis of side-chain substituted Arg and hArg derivatives in peptide drug discovery platforms. en_US
dc.language.iso en_US en_US
dc.subject alkylated-homoarginine en_US
dc.subject Ganirelix impurities en_US
dc.subject Ganirelix peptide drug en_US
dc.subject generic drug en_US
dc.subject peptide synthesis en_US
dc.title Synthesis and characterization of two potential impurities (desethyl-Ganirelix) generated in the Ganirelix manufacturing process en_US
dc.type Article en_US


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