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药品水分测定方法的选择及策略

周浩, 王慧洁, 赵媛媛, 王欢, 张士博

周浩, 王慧洁, 赵媛媛, 王欢, 张士博. 药品水分测定方法的选择及策略[J]. 中国药科大学学报, 2022, 53(1): 113-119. DOI: 10.11665/j.issn.1000-5048.20220117
引用本文: 周浩, 王慧洁, 赵媛媛, 王欢, 张士博. 药品水分测定方法的选择及策略[J]. 中国药科大学学报, 2022, 53(1): 113-119. DOI: 10.11665/j.issn.1000-5048.20220117
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ZHOU Hao, WANG Huijie, ZHAO Yuanyuan, WANG Huan, ZHANG Shibo. Selection and strategy of water determination methods in pharmaceuticals[J]. Journal of China Pharmaceutical University, 2022, 53(1): 113-119. DOI: 10.11665/j.issn.1000-5048.20220117
Citation: ZHOU Hao, WANG Huijie, ZHAO Yuanyuan, WANG Huan, ZHANG Shibo. Selection and strategy of water determination methods in pharmaceuticals[J]. Journal of China Pharmaceutical University, 2022, 53(1): 113-119. DOI: 10.11665/j.issn.1000-5048.20220117
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药品水分测定方法的选择及策略

  • 正大天晴药业集团股份有限公司，南京 211100

Selection and strategy of water determination methods in pharmaceuticals

  • Chia Tai Tianqing Pharmaceutical Co., Ltd., Nanjing 211100, China

摘要

    摘要
  • 摘要: 水分测试贯穿于药品研发、生产、储存及使用全过程，是药品质量研究的重要内容。选择准确、可靠的测试方法测定水分含量，对于药品的质量控制至关重要。本文介绍了国内外药典水分测试通则和应用实例，结合对供试品结构、溶解性、含水量的分析，综述了药品水分测试方法的选择与研究思路，旨在为水分测试方法的开发和质量标准的制订提供依据。
    Abstract: Water content determination is an important aspect of quality research in the whole process of pharmaceutical development, production, storage and use.Therefore, it is significant to develop an accurate and robust method for the determination of water content in the quality control of pharmaceuticals.In this article, the selection and strategy for the study of water determination methods are explained on the basis of general water determination principles and application examples in Chinese and foreign pharmacopoeias, together with the analysis of sample structure, solubility and water content.This article aims to provide basis for the development of moisture testing methods and formulation of proper quality standards for pharmaceuticals.
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    • 参考文献(23)
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出版历程
  • 收稿日期:  2021-06-07
  • 修回日期:  2022-01-06
  • 刊出日期:  2022-02-24

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