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