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- 江奈 英里
- エーザイ株式会社DHBL Pharmaceutical Profiling & Development Function Pharmaceutical Science & Technology Unit分析研究部
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- 浅井 由美
- エーザイ株式会社DHBL Pharmaceutical Profiling & Development Function Pharmaceutical Science & Technology Unit分析研究部
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- 長谷部 隆
- エーザイ株式会社DHBL Pharmaceutical Profiling & Development Function Pharmaceutical Science & Technology Unit分析研究部
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- 大江 浩志
- エーザイ株式会社プロダクトクオリティ本部日本・アジアリージョナルクオリティ統括部鹿島品質管理部
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- 広瀬 修市
- エーザイ株式会社プロダクトクオリティ本部日本・アジアリージョナルクオリティ統括部鹿島品質管理部
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- 高橋 嘉政
- エーザイ株式会社プロダクトクオリティ本部日本・アジアリージョナルクオリティ統括部鹿島品質管理部
書誌事項
- タイトル別名
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- The Applications of qNMR in Drug Quality Control
抄録
<p>NMR is well known as one of the most important methods for elucidating the structure of organic compounds. Furthermore, it has recently been recognized as a powerful tool for quantitative analysis. The quantitative NMR (qNMR) has become an official analytical method described in detail in the Japanese Pharmacopoeia. And today, it is widely applied in drug development. The qNMR method offers many new advantages over traditional and conventional quantitative analysis methods. For example, this method requires only a few milligrams of the analyte and allows absolute quantitation of the analyte without using a qualified reference standard as a control sample. Then, it can be easily applied to most chemicals without expending significant time and resources on method development. In addition, residual solvent can be determined using qNMR methods. The peak area of an NMR spectrum is directly proportional to the number of protons contributing to the resonance. Based on this principle, the residual solvent can be determined by counting the signal corresponding to the residual solvent in the sample solution. We have applied qNMR as an alternative to GC. Thus, qNMR is an innovative and promising analytical technique that is expected to make significant progress in the future. Recently, the analytical research and quality control departments have been working together to expand this technology to a wide range of areas in the pharmaceutical industry.</p>
収録刊行物
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- 薬学雑誌
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薬学雑誌 144 (4), 381-385, 2024-04-01
公益社団法人 日本薬学会