Characterization and stability of S (-) pantoprazole sodium hydrates.
- Author:
Chen BEI
1
;
Zhang LIBO
2
;
L I HONG
2
;
Tang GUPING
3
;
H U XIURONG
4
Author Information
1. School of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
2. Hangzhou Huadong Medicine Group Pharmaceutical Research Institute Co., Ltd, Hangzhou 310011, China.
3. Department of Chemistry, Zhejiang University, Hangzhou 310028, China. tangguping@zju.edu.cn.
4. Department of Chemistry, Zhejiang University, Hangzhou 310028, China. huxiurong@zju.edu.cn.
- Publication Type:Journal Article
- From:
Journal of Zhejiang University. Medical sciences
2017;46(2):160-166
- CountryChina
- Language:Chinese
-
Abstract:
To study the characteristics and stability of new S(-) pantoprazole sodium hydrates.The X-ray single crystal diffractometer (SXRD), X-ray powder diffractometer (PXRD), thermogravimetric analysis (TG) and infrared spectrometry (IR) were used to characterize S(-) pantoprazole sodium hydrates. The stability of the hydrates was evaluated by high temperature test,affecting factors test and accelerated test.The crystalline water in S(-) pantoprazole sodium hydrates were very easy to lose and obtain, but crystal structure was not changed significantly. The transition from S(-) pantoprazole sodium trihydrate to S(-) pantoprazole sodium hemipentahydrate occurred at approximately 40 ℃ and reversible transitions from hemipentahydrate to trihydrate occurred at high humidity. Two hydrates had no significant difference in accelerated test.The crystal structure of the two hydrates are almost the same, hemipentahydrate is more stable than trihydrates at high temperature or at exposure to light(at 4500 ± 500 lx).
