甲磺酸達比加群酯制劑工藝中溶劑的選擇
發(fā)布時間:2018-09-13 21:32
【摘要】:采用水、乙醇、異丙醇、磷酸溶液、鹽酸溶液等不同溶劑,測試甲磺酸達比加群酯(采用晶型Ⅰ)在25℃條件下的溶解度,并通過晶型的監(jiān)測,選擇合適的工藝溶劑。結(jié)果表明,氯離子、磷酸根離子可降低甲磺酸達比加群酯的溶解度;在水及乙醇飽和溶液中,5 min就明顯轉(zhuǎn)晶,但在異丙醇飽和溶液中2 h內(nèi)沒有明顯轉(zhuǎn)晶;表明異丙醇可優(yōu)先考慮作為工藝溶劑使用,從而降低轉(zhuǎn)晶的風險,為確保貨架期內(nèi)的產(chǎn)品質(zhì)量提供保障。
[Abstract]:Water, ethanol, isopropanol, phosphoric acid solution and hydrochloric acid solution were used to test the solubility of dapi group ester (using crystal form I) at 25 鈩,
本文編號:2241803
[Abstract]:Water, ethanol, isopropanol, phosphoric acid solution and hydrochloric acid solution were used to test the solubility of dapi group ester (using crystal form I) at 25 鈩,
本文編號:2241803
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