Force Degradation of an Oligonucleotide - A Case Study

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Antisense oligonucleotides (ASO) stability-indicating test demand has increased significantly within the CRO industry. The demand is specifically for the most commonly used method to monitor the purity and impurity profiles of an oligonucleotide. The IP-RP-HPLC-UV-MS method, which uses ion-pairing (IP) reversed-phase (RP) chromatography coupled with both ultraviolet (UV) and mass spectrometry (MS) detections in parallel. The purity and impurity profile of these oligonucleotides are relatively stable and typically show an increase of common degradants throughout the course of a stability study. These common degradants coelute with the main component making quantitation an important focus. Herein we examine a “real life” scenario for the forced degradation study on the effects of heat and oxidation on antisense oligonucleotides with analysis by IP-RP-HPLC-UV-MS.

Force Degradation of an Oligonucleotide – A PPD Case Study

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