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1 Purity Analysis and Impurities Determination by …

11 Purity Analysis and Impurities Determination by Reversed-Phase High-Performance Liquid ChromatographyHagen Cramer, Kevin J. Finn, and Eric HerzbergGirindus America, , IntroductIonThe increasing significance of oligonucleotides as therapeutic agents necessitates a high level of quality control. In such protocols, chromatographic Analysis of crude and final active pharmaceu-tical ingredients (API) is necessary to ensure the detection of contaminants at concentration lev-els down to trace amounts relative to the drug. A combination of chromatographic techniques, in particular reverse-phased high-performance liquid chromatography (RP-HPLC), anion-exchange (AEX) HPLC (Chapter 2), and mass spectrometry (Chapters 4 and 5), is needed for the identification and structural elucidation of by-products and degradation products resulting from the production Introduction .. Historical Aspects.

1 1Purity Analysis and Impurities Determination by Reversed-Phase High-Performance Liquid Chromatography Hagen Cramer, Kevin J. Finn, and Eric Herzberg Girindus America, Inc. Cincinnati, Ohio

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