Equivalence Studies of Different Methods for Drug Melting Point Determination
XIONG Jing1, WU Jian-min1, WANG Si-cen2,LIU Xin-she2,XIANG Xin-hua1,ZHAO Hai-shan3, NING Bao-ming1*, HE Lan1*
1. National Institutes for Food and Drug Control, Beijing 102629, China; 2. School of Pharmacy, Xi��an Jiaotong University, Xi��an 710061, China; 3. Tianda Tianfa Technology Co., Ltd., Tianjin 300072, China
Abstract��OBJECTIVE To evaluate the equivalence among three different methods for drug melting point determination:��method A1 by glass liquid thermometer, ��method A2 by digital display,and �� method B by instrumental method. METHODS Five chemical reference substances with different melting points were selected as the target drugs, and different brands of melting point apparatus were used to determine melting point. The apparatus used by method A consists of a glass container for a liquid bath and fitted with a suitable means of heating.The obtained results of the melting point by method A1, A2 and B were evaluated by equivalence testing referring to the data of Proficiency Testing Scheme for the melting point determination of chemical drugs organized by NIFDC in 2015 and 2016. RESULTS Method A1, A2 and B were equivalent,and no significant difference were observed for the melting point values determined by the three methods. CONCLUSION There is no significant difference between the melting point determination method A and method B in the Chinese Pharmacopoeia(Ch.P), and the obtained melting point values are equivalent either by glass liquid thermometer or digital display while using method A. This experiment provides scientific data support for potential adoption of digital display in melting point apparatus by Ch.P.
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XIONG Jing, WU Jian-min, WANG Si-cen,LIU Xin-she,XIANG Xin-hua,ZHAO Hai-shan, NING Bao-ming, HE Lan. Equivalence Studies of Different Methods for Drug Melting Point Determination. Chinese Pharmaceutical Journal, 2018, 53(21): 1861-1868.
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2018, Vol. 53 
