Oligonucleotides are an emerging class of drugs that are manufactured by solid‐phase synthesis. As a chemical class, they have unique product‐related impurities and degradants, characterization of which is an essential step in drug development. The synthesis cycle, impurities produced during the synthesis and degradation products are presented and discussed. The use of liquid chromatography combined with mass spectrometry for characterization and quantification of product‐related impurities and degradants is reviewed. In addition, sequence determination of oligonucleotides by gas‐phase fragmentation and indirect mass spectrometric methods is discussed. © 2019 John Wiley & Sons Ltd. Mass Spec Rev

中文翻译：

---

治疗性寡核苷酸、杂质、降解物及其质谱表征

寡核苷酸是一类通过固相合成制造的新兴药物。作为一类化学物质，它们具有独特的与产品相关的杂质和降解物，对其进行表征是药物开发的重要步骤。介绍和讨论了合成周期、合成过程中产生的杂质和降解产物。综述了液相色谱与质谱联用在产品相关杂质和降解物的表征和定量中的应用。此外，还讨论了通过气相断裂和间接质谱法测定寡核苷酸的序列。© 2019 John Wiley & Sons Ltd. 质谱修订版