THERAPEUTIC OLIGONUCLEOTIDES, IMPURITIES, DEGRADANTS, AND THEIR CHARACTERIZATION BY MASS SPECTROMETRY

被引：52
作者：
Pourshahian, Soheil [1 ]
机构：
[1] Janssen Pharmaceut Co Johnson & Johnson, San Francisco, CA 94080 USA
来源：
MASS SPECTROMETRY REVIEWS | 2021年 / 40卷 / 02期
关键词：
oligonucleotide; siRNA; antisense; quantitative; qualitative; analysis; degradation; impurity; mass spectrometry; LC-MS; HPLC; TIME-OF-FLIGHT; PERFORMANCE LIQUID-CHROMATOGRAPHY; CHEMICALLY-MODIFIED OLIGONUCLEOTIDES; INFRARED MULTIPHOTON DISSOCIATION; COLLISION-INDUCED DISSOCIATION; ELECTRON-CAPTURE DISSOCIATION; DNA-SEQUENCING REACTIONS; 193 NM PHOTODISSOCIATION; SOLID-PHASE EXTRACTION; ION-PAIRING REAGENTS;
D O I：
10.1002/mas.21615
中图分类号：
O433 [光谱学];
学科分类号：
0703 ; 070302 ;
摘要：
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. (c) 2019 Wiley Periodicals, Inc. Mass Spec Rev
引用
收藏
页码：75 / 109
页数：35
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