Establishment of National Reference Standards of Sulfadimidine Impurities
YANG Qing1,2, LIU Ying2, LIU Shu-yu3, TIAN Ye2, MA Bu-fang2, ZHANG Xia2, FENG Yan-chun2, YAO Shang-chen2, LIU Wan-hui1,YIN Li-hui2*
1. Yantai University, Yantai 264003,China; 2. National Institutes for Food and Drug Control, Beijing 100050, China; 3. Shanghai University of Engineering Science, Shanghai 201620, China
Abstract：OBJECTIVE To establish the national reference standards of sulfadimidine impurities thus to provide guarantee for improving the standard of quality control of sulfadiazine in China. METHODS First, the structures of sulfadimidine impurities A and E were validated by infrared spectrocopy, mass spectrum and nuclear magnetic resonance method. Then, the purities of impurities A and E were determined using the method of related substance test for sulphadiazine in the European Pharmacopoeia (version 9.0),their water content and residue on ignition were determined as well. The contents of sulfadimidine impurities A and E were determined by using mass balance method. Meanwhile, external standard method and nuclear magnetic quantitative method were used to calculate the content, which were mutually verified with the mass balance method. Finally, the correction factors of sulfadiazine impurities A and E at 241 nm were determined using standard curve method. RESULTS The structures of sulfadimidine impurities A and E were confirmed, and the contents of impurities A and E were 99.1% and 98.7%, respectively, which were calculated by mass balance method. The results were consistent with those obtained from external standard method and nuclear magnetic quantification method. The correction factors of impurities A and E to sulfadimidine were 0.97 and 0.63, respectively. CONCLUSION The first batch of national standard substances of sulfadimidine impurities A and E were established successfully.
杨青, 刘颖, 刘书妤, 田冶, 马步芳, 张夏, 冯艳春, 姚尚辰, 刘万卉, 尹利辉. 磺胺二甲嘧啶有关杂质国家标准物质的研制[J]. 中国药学杂志, 2019, 54(24): 2082-2086.
YANG Qing, LIU Ying, LIU Shu-yu, TIAN Ye, MA Bu-fang, ZHANG Xia, FENG Yan-chun, YAO Shang-chen, LIU Wan-hui,YIN Li-hui. Establishment of National Reference Standards of Sulfadimidine Impurities. Chinese Pharmaceutical Journal, 2019, 54(24): 2082-2086.
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2019, Vol. 54 
