Abstract：OBJECTIVE To study the structure and source of degradation impurities of national reference standards of 5-nitro-2-furaldehyde diacetate. METHODS Firstly, high performance liquid chromatographic method (HPLC)and high performance liquid-high resolution mass spectrometry (HPLC-HRMS)were adopted to analyze the impurities structure of national reference standards of 5-nitro-2-furaldehyde diacetate stored for long time. Furthermore,the degradation pathways of impurities was further explored through the stress testing(high temperature, high humidity, and light). RESULTS The major impurity of long-term storage national reference standards of 5-nitro-2-furaldehyde diacetate was 5-nitro-2-furaldehyde. The results of stress testing showed that high temperature was the main factor of degradation. The packaging of brown sill in Xilin bottle had no protective effect in high humidity, but had certain protective effect under the strong light. CONCULUSION The 5-nitro-2-furaldehyde diacetate is unstable and susceptible to external conditions. In the development of national reference materials, attention should be paid to the selection of packaging and storage conditions.
杨青, 田冶, 张夏, 刘颖, 尹利辉. 5-硝基糠醛二乙酸酯国家标准物质降解杂质研究[J]. 中国药学杂志, 2021, 56(23): 1949-1952.
YANG Qing, TIAN Ye, ZHANG Xia, LIU Ying, YIN Li-hui. Degradation Impurities Study of National Reference Standards of 5-Nitro-2-Furaldehyde Diacetate. Chinese Pharmaceutical Journal, 2021, 56(23): 1949-1952.
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2021, Vol. 56 
