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| Study on Salifying Process of Dronedarone |
| HU Yong-liang, WANG Bing-lin, RONG Yan-hua, GUO Xiao-feng, YU Pu |
| CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Corporation Ltd., Shijiazhuang 050015,China |
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Abstract Dronedarone hydrochloride is a kind of new antiarrhythmic drug.It was synthesized by adding hydrogen chloride ethanol to dronedarone dissolved in ethyl acetate.The effects of reaction solvent,the solvent of hydrogen chloride,the amount of hydrogen chloride in ethanol were examined.The results showed that the purity of the recrystallized product was 99.9% and the yield was 48.4%,the improved salifying process avoided use of anhydrous ethyl acetate and combustible ethers, which had lower production cost and higher production safety .
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