建立藥物分析方法：(I)不純物分析與強迫降解實驗

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).