摘要
二甲基乙酰胺(DMA)是一种重要的非质子极性溶剂,广泛应用于生物医药、化工合成及纺丝材料等领域。随着应用场景的不断拓展,尤其是创新药与新型制剂的发展,对DMA的纯度、杂质控制及安全性提出了更高要求。本文系统梳理了DMA在不同领域中的质量要求、关键质量属性(如水分、有关物质)、检测方法(包括气相色谱、高效液相色谱、色谱–质谱联用及热分析技术)以及环保安全方面的研究进展。目前,我国尚未建立针对药用辅料DMA的专项质量标准,现有标准多参照国外药典,在杂质控制(如基因毒性杂质NMA、热分解杂质TMA)与国内产业实际适配方面存在不足。未来需结合中国毒理学数据和产业现状,建立科学、严格的质量标准体系,以提升DMA的整体质量与安全性,支持医药产业的高质量发展。
Dimethylacetamide (DMA) is an important aprotic polar solvent widely used in biopharmaceuticals, chemical synthesis, and spinning materials. With the expansion of its application scenarios, especially in innovative drugs and novel formulations, higher requirements have been placed on the purity, impurity control, and safety of DMA. This paper systematically reviews the quality requirements of DMA in different fields, key quality attributes (such as moisture and related substances), detection methods (including gas chromatography, high-performance liquid chromatography, chromatography-mass spectrometry, and thermal analysis techniques), and research progress in environmental and safety aspects. Currently, China has not yet established a dedicated quality standard for DMA as a pharmaceutical excipient. Existing standards mostly refer to foreign pharmacopoeias, which lack specificity in impurity control (e.g., genotoxic impurities like NMA and thermal decomposition impurities like TMA) and are insufficiently adapted to domestic industrial practices. In the future, it is necessary to establish a scientific and stringent quality standard system based on Chinese toxicological data and industrial realities, thereby enhancing the overall quality and safety of DMA and supporting the high-quality development of the pharmaceutical industry.
出处
《药物化学》
2026年第1期8-15,共8页
Hans Journal of Medicinal Chemistry
基金
2025年度国家药品标准制修订硏究课题(BZ2025110)。
