- 专利标题： METHOD OF DETERMINING THE MOLECULAR WEIGHT DISTRIBUTION OF GLATIRAMER ACETATE USING MULTI-ANGLE LASER LIGHT SCATTERING (MALLS)
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申请号： US15570030申请日： 2016-04-29
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公开(公告)号： US20180164275A1公开(公告)日： 2018-06-14
- 发明人: Avraham Arthur KOMILOSH , Dalia PINKERT
- 申请人： Avraham Arthur KOMILOSH , Dalia PINKERT
- 申请人地址： IL Petach Tikva
- 专利权人： Teva Pharmaceutical Industries Ltd.
- 当前专利权人： Teva Pharmaceutical Industries Ltd.
- 当前专利权人地址： IL Petach Tikva
- 国际申请： PCT/US2016/030277 WO 20160429
- 主分类号： G01N33/44
- IPC分类号： G01N33/44 ; C08G69/10 ; G01N21/47 ; G01N30/89 ; G01N30/06 ; C08G69/46
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.
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