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

作者信息

Hvass A, Skelbaek-Pedersen B

机构信息

Novo Nordisk A/S, Novo Alle, 2880 Bagsvaerd, Denmark.

出版信息

J Pharm Biomed Anal. 2005 Mar 9;37(3):551-7. doi: 10.1016/j.jpba.2004.11.028. Epub 2004 Dec 19.

DOI:10.1016/j.jpba.2004.11.028
PMID:15740916
Abstract

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.

摘要

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