We examined the separation conditions for impurities in nucleic acid pharmaceuticals using ion mobility and confirmed the separation of nucleic acid impurities such as deletions and desulfurized bodies.
The technical information magazine The TRC News provides the latest information on analytical techniques that are useful for research and development, resolving production troubles, and quality control. **Abstract** Nucleic acid drugs generate impurities such as nucleotide deletions, adducts, and desulfurated forms during their synthesis process. Additionally, thiophosphate modifications aimed at improving the safety and efficacy of nucleic acid drugs can lead to the formation of stereoisomers due to the chiral nature of phosphorus atoms. Separating and purifying these impurities and isomers can pose challenges in the quality control of nucleic acid drugs. Ion mobility is a new technology that separates ionized compounds based on differences in collision cross-section area and charge, and it is gaining attention as an effective means for separating these impurities. In this study, we investigated the separation conditions for these impurities using ion mobility and confirmed the separation of nucleic acid impurities such as deletions and desulfurated forms. **Table of Contents** 1. Introduction 2. Ion Mobility Separation 3. Analytical Examples 4. Conclusion 5. Final Remarks
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Technical Information Magazine The TRC News "Separation of Impurities in Nucleic Acid Pharmaceuticals by Ion Mobility" [Abstract] Nucleic acid pharmaceuticals generate impurities such as nucleotide deletions, adducts, and desulfurized forms during their synthesis. Additionally, thiophosphate modifications aimed at improving the safety and efficacy of nucleic acid pharmaceuticals introduce stereoisomers due to the chiral nature of phosphorus atoms. Separating and purifying these impurities and isomers has become a challenge in the quality control of nucleic acid pharmaceuticals. Ion mobility is a new technology that separates ionized compounds based on differences in collision cross-section and charge, and it is gaining attention as an effective means for separating these impurities. In this study, we examined the separation conditions for these impurities using ion mobility and confirmed the separation of nucleic acid impurities such as deletions and desulfurized forms. [Table of Contents] 1. Introduction 2. Ion Mobility Separation 3. Analytical Examples 4. Conclusion 5. Final Remarks [Figures and Tables] Figures 1-11 Analytical Data Table 1 Deconvolution Analysis Results
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At Toray Research Center, Inc., we provide technical support through analytical techniques and physical property analysis to address various challenges in research and development as well as production fields via contract analysis. Based on our long-standing achievements and extensive experience in analysis and physical property evaluation, we continue to strive to meet the advanced and diverse needs of our customers.