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Peptide and Protein Quantification Using Automated Immuno-MALDI (iMALDI)
Published on: August 18, 2017
Determination of protamine peptides in insulin drug products using reversed phase high performance liquid
1Novo Nordisk A/S, Novo Alle, 2880 Bagsvaerd, Denmark. aahv@novonordisk.com
Journal of Pharmaceutical and Biomedical Analysis
|March 3, 2005
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.
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