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公开(公告)号:US20180164275A1
公开(公告)日:2018-06-14
申请号:US15570030
申请日:2016-04-29
CPC分类号: G01N33/442 , C08G69/10 , C08G69/46 , G01N21/47 , G01N30/06 , G01N30/74 , G01N30/89 , G01N33/68 , G01N2021/4711
摘要: The present invention provides a process for characterizing a glatiramer acetate, related drug substance (GARDS) or a glatiramer acetate related drug product (GARDP) comprising separating a batch of a GARDS or GARDP according to hydrophobicity and determining the molar mass of the separated material, thereby characterizing the GARDS or GARDP by molar mass as a function of hydrophobicity.