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A Multidisciplinary Investigation to Determine the Structure and Source of Dimeric Impurities in AMG 517 Drug Substance

In the initial scale-up batches of the experimental drug substance AMG 517, a pair of unexpected impurities was observed by HPLC. Analysis of data from initial LC-MS experiments indicated the presence of two dimer-like molecules. One impurity had an additional sulfur atom incorporated into its struc...

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Detalles Bibliográficos
Autores principales: Silva Elipe, Maria Victoria, Tan, Zhixin Jessica, Ronk, Michael, Bostick, Tracy
Formato: Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2009
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2814138/
https://www.ncbi.nlm.nih.gov/pubmed/20140079
http://dx.doi.org/10.1155/2009/768743