Determination of protamine peptides in insulin drug products using reversed phase high performance liquid chromatography
spring119 添加于 2015-6-1 11:06
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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年 第37卷 第3期 551-557页
- 地址: Novo Nordisk A/S, Novo Alle, 2880 Bagsvaerd, Denmark. aahv@novonordisk.com
- ISBN: 0731-7085
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