Characterization And Stability Of New S(-)Pantoprazole Sodium Hydrates API

To study the characterization and stability of the new S(-)pantoprazole sodium hydrate.To establish the quality standard of S(-)pantoprazole sodium hemipentahydrate API and investigate its stability.The X-ray single crystal diffractometer(SXRD),X-ray powder diffractometer(PXRD),thermogravimetric analysis(TG)and Infrared spectrometry(IR)were used to perform detailed characterization of S(-)pantoprazole sodium hydrates(Comparison between S(-)pantoprazole sodium hemipentahydrate and S(-)pantoprazole sodium trihydrate).The stability of the hydrates were evaluated by high temperature test,affecting factors test and accelerated test(Comparison between S(-)pantoprazole sodium hemipentahydrate and S(-)pantoprazole sodium trihydrate).The quality standard of S(-)pantoprazole sodium hemipentahydrate API was established with HPLC methed.Investigate the related substances,optical isomer and content determination.And than study the stability of S(-)pantoprazole sodium hemipentahydrate API.The crystalline water in S(-)pantoprazole sodium hydrates were very easy to lose and obtain,but crystal structure will not change significantly.Transition from S(-)pantoprazole sodium trihydrate to S(-)pantoprazole sodium hemipentahydrate occurs at high temperature approximately 45 ? and reversible transitions from hemipentahydrate to trihydrate occur at high humidity.Hemipentahydrate is more stable than trihydrates at high temperature 40? or exposured to light(at 4500±5001x).Both two hydrates had no significant change in accelerated test.After the verification methodology,the quality control methods have characteristics about accurate specificity,recovery rate and precision,and having a better product quality control.The stability test showed that no obvious change with different evaluation indexes after investigated 6 months in the affecting factors test and 24 month in the long-termexperiments about S(-)pantoprazole sodium hemipentahydrate API.The crystal structure of the two hydrates are almost the same,hemipentahydrate is more stable than trihydrates.The S(-)pantoprazole sodium hemipentahydrate API is relatively stability.