Application of Residual Solvents Determination Method in Chinese Pharmacopoeia 2015 Edition
LIU Ying1, WANG Zhi-jun2, DONG Xin1, XUE Jing1, ZHU Feng-chang3, HU Chang-qin1*
1. National Institutes for Food and Drug Control, Beijing 100050, China; 2. Chinese Pharmacopoeia Commission, Beijing 100061, China; 3. Chinese Pharmaceutical Association, Beijing 100022, China
Abstract��OBJECTIVE To introduce the application of the residual solvents determination methods in general chapter 0861 of Chinese pharmacopoeia 2015 edition. METHODS Determination of the residual solvents of cefathiamidine was chosen as an example to indicate that how to use the residual solvents determination methods in general chapter 0861 of Chinese pharmacopoeia 2015 edition when the methods for the determination of residual solvent in monograph of cefathiamidine did not work. RESULTS The residual solvents in cefathiamidine from different manufactures were determined accurately using methods in general chapter 0861 of Chinese pharmacopoeia 2015 edition. CONCLUSION The residual solvents determination methods in general chapter 0861 of Chinese pharmacopoeia 2015 can be used to screening and confirm the unknown peaks by the two opposite polar column systems, which can help to establish the residual solvents method.
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LIU Ying, WANG Zhi-jun, DONG Xin, XUE Jing, ZHU Feng-chang, HU Chang-qin. Application of Residual Solvents Determination Method in Chinese Pharmacopoeia 2015 Edition. Chinese Pharmaceutical Journal, 2017, 52(17): 1558-1562.
2017, Vol. 52 
