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Determination of protamine peptides in insulin drug products using reversed phase high performance liquid chromatography

spring119 添加于 2015-6-1 11:06 | 1054 次阅读 | 0 个评论
  •  作 者

    Hvass A, Skelbaek-Pedersen B
  •  摘 要

    This paper describes the establishment and validation of a reversed phase HPLC (RP-HPLC) method for determination of protamine peptides in protamine sulphate raw material and insulin drug products, discusses the analytical results obtained for a number of protracted insulin formulations and the potential of the method in connection with protamine sulphate raw material and final drug product quality control.
  •  详细资料

    • 关键词: Chromatography, High Pressure Liquid/methods; Insulin/*analysis; Peptides/*analysis; Protamines/*analysis
    • 文献种类: Journal Article
    • 期刊名称: Journal of Pharmaceutical and Biomedical Analysis
    • 期刊缩写: J Pharm Biomed Anal
    • 期卷页: 2005  37 3 551-557
    • 地址: Novo Nordisk A/S, Novo Alle, 2880 Bagsvaerd, Denmark. aahv@novonordisk.com
    • ISBN: 0731-7085
  • 学科领域 生物医药 » 药学

  • 相关链接 DOI URL 

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