Purity Analysis and Impurities Determination by Reversed- Phase High-Performance Liquid Chromatography
نویسندگان
چکیده
The increasing significance of oligonucleotides as therapeutic agents necessitates a high level of quality control. In such protocols, chromatographic analysis of crude and final active pharmaceutical ingredients (API) is necessary to ensure the detection of contaminants at concentration levels 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 contents
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