Back to Search Start Over

Identification, synthesis, and characterization of an unprecedented N‐(2‐carboxyethyl) adduct impurity in an injectable ganirelix formulation.

Authors :
Jadav, Rohit
Kameriya, Ramraj
Chatterjee, Saurav
Gour, Vinod
Purohit, Parva
Bandyopadhyay, Anupam
Source :
Journal of Peptide Science; May2024, Vol. 30 Issue 5, p1-9, 9p
Publication Year :
2024

Abstract

Ganirelix, a peptide‐based drug used to treat female infertility, has been in high market demand, which attracted generic formulation. A hitherto unknown impurity of ganirelix was observed in our formulation process, which reached ~0.3% in 6 months and led to a detailed investigation of its structure. In‐depth analysis of ESI‐MS/MS data of this impurity coupled with an artificial intelligence prediction tool led to a highly unusual putative structure, that is, N‐(2‐carboxyethyl)‐ganirelix (NCE‐GA), which was authenticated by chemical synthesis from ganirelix and NMR analysis and via corroborated HPLC and MS/MS data with the formulation‐derived impurity. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
10752617
Volume :
30
Issue :
5
Database :
Complementary Index
Journal :
Journal of Peptide Science
Publication Type :
Academic Journal
Accession number :
176450713
Full Text :
https://doi.org/10.1002/psc.3564