建立藥物分析方法：(I)不純物分析與強迫降解實驗

Method Development for Pharmaceutical Analysis: (I) Impurity Method and Forced Degradation Tests

劉公典(Kung-Tien Liu) ； 夏儀芝(Yi-Chih Hsia) ； 楊漢興(Hang-Hsing Yang) ； 蔡慧穎(Hui-Yin Tsai) ； 沈立漢(Lie-Hang Shen)

《化學》 67卷1期 (2009/03) Pp. 67-81

https://doi.org/10.6623/chem.2009006

摘要

不純物分析是確認藥物或藥品一致性、安全、品質與純度的主要基本議題。本文整理管制機構，如美國食品藥物管理局、美國藥典與國際醫藥法規協合會，對不純物分析的法規要求。發展不純物分析方法比發展有效成分分析方法更加複雜。因此本文也分別討論程序不純物與降解不純物二類不純物的分析技術，包括強迫降解實驗與定量技術。希望提供從事藥物發現與發展工作之藥物學家及化學家更深入的認識與幫助。

關鍵字

藥物分析 ； 不純物分析 ； 強迫降解實驗 ； 分析方法 ； 分析方法確效

並列摘要

Profiling of impurities in drugs is an essential issue to ensure the identity, safety, quality, and purity of drug substances or drug products. In this article, requirements for the impurity method from regulatory authorities, such as US Food and Drug Administration (FDA), US Pharmacopeia (USP), International Conference on Harmonization (ICH) are reviewed. Development of impurity assay method is much more complicated than the active pharmaceutical ingredient (API) assay method. Two categories of impurities, called process-related impurities (PRIs) and degradation-related impurities (DRIs) are well defined. Forced degradation test and analytical methodologies for the quantification of unknown impurities are discussed. We intend to provide a deeper understanding and aid to pharmaceutical scientists and chemists who engage in drug discovery and development (DD&D).

並列關鍵字

Pharmaceutical analysis ； Impurities analysis ； Forced degradation ； Analytical methodology ； Method validation