Characterization and stability of (S)-pantoprazole sodium hydrates

VernacularTitle:新型左旋泮托拉唑钠水合物晶型结构及稳定性研究
Author: Bei CHEN ¹ ; Libo ZHANG ; Hong LI ; Guping TANG ; Xiurong HU
Author Information

1. 浙江大学药学院
Keywords: Benzimidazoles/analysis; Sodium; Drug stability; X-ray diffraction; Water; Lens,cystalline/anatomy & histology
From: Journal of Zhejiang University. Medical sciences 2017;46(2):153-159
CountryChina
Language:Chinese
Abstract: Objective:To study the characteristics and stability of new (S)-pantoprazole sodium hydrates.Methods: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.Results: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.Conclusion:The crystal structure of the two hydrates are almost the same,and hemipentahydrate is more stable than trihydrates at high temperature or at exposure to light[at (4500 ± 500)lx].