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Identification, synthesis, and characterization of an unprecedented N-(2-carboxyethyl) adduct impurity in an injectable ganirelix formulation.
Jadav, Rohit; Kameriya, Ramraj; Chatterjee, Saurav; Gour, Vinod; Purohit, Parva; Bandyopadhyay, Anupam.
Afiliación
  • Jadav R; Kashiv BioSciences Pvt Ltd., Ahmedabad, Gujarat, India.
  • Kameriya R; Biomimetic Peptide Engineering Laboratory, Department of Chemistry, Indian Institute of Technology Ropar, Ropar, Punjab, India.
  • Chatterjee S; Biomimetic Peptide Engineering Laboratory, Department of Chemistry, Indian Institute of Technology Ropar, Ropar, Punjab, India.
  • Gour V; Biomimetic Peptide Engineering Laboratory, Department of Chemistry, Indian Institute of Technology Ropar, Ropar, Punjab, India.
  • Purohit P; Kashiv BioSciences Pvt Ltd., Ahmedabad, Gujarat, India.
  • Bandyopadhyay A; Biomimetic Peptide Engineering Laboratory, Department of Chemistry, Indian Institute of Technology Ropar, Ropar, Punjab, India.
J Pept Sci ; 30(5): e3564, 2024 May.
Article en En | MEDLINE | ID: mdl-38131153
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Inteligencia Artificial / Hormona Liberadora de Gonadotropina / Espectrometría de Masas en Tándem Límite: Female / Humans Idioma: En Revista: J Pept Sci Asunto de la revista: BIOQUIMICA Año: 2024 Tipo del documento: Article País de afiliación: India Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Inteligencia Artificial / Hormona Liberadora de Gonadotropina / Espectrometría de Masas en Tándem Límite: Female / Humans Idioma: En Revista: J Pept Sci Asunto de la revista: BIOQUIMICA Año: 2024 Tipo del documento: Article País de afiliación: India Pais de publicación: Reino Unido