发明授权
- 专利标题： Quantification of impurities for release testing of peptide products
- 专利标题（中）： 定量杂质用于肽产品的释放测试
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申请号： US13870288申请日： 2013-04-25
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公开(公告)号： US08901484B2公开(公告)日： 2014-12-02
- 发明人: Martin Vogel , Werner Mueller
- 申请人： Sanofi-Aventis Deutschland GmbH
- 申请人地址： DE Frankfurt am Main
- 专利权人： Sanofi-Aventis Deutschland GmbH
- 当前专利权人： Sanofi-Aventis Deutschland GmbH
- 当前专利权人地址： DE Frankfurt am Main
- 优先权： EPPCT/EP2012/057771 20120427
- 主分类号： H01J49/26
- IPC分类号： H01J49/26 ; G01N33/68 ; H01J49/00
摘要：
The present invention relates to a method for the quantitative determination of an impurity present in a peptide product, wherein the impurity cannot be separated from other impurities or the main product. The method particularly involves the use of high resolution mass spectrometry (MS) detection with or without high performance liquid chromatography (HPLC). The method can be used for the investigation of the quality of peptides and proteins, particularly of pharmaceutical peptides and proteins.
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