Composition of 5-fluorouracil and refining method therefor
AssigneeShanghai Xudong Haipu Pharmaceutical Co., Ltd
InventorsXiaolin Chen, Pengfei Gao, Yike Yang, Yi Liang, Yafeng Zhan
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AssigneeShanghai Xudong Haipu Pharmaceutical Co., Ltd
InventorsXiaolin Chen, Pengfei Gao, Yike Yang, Yi Liang, Yafeng Zhan
Estimating the term…
Disclosed is a method for refining 5-fluorouracil, comprising the following steps: dissolving 5-fluorouracil in an organic solvent, preferably DMSO, heating and stirring until dissolved; naturally cooling the filtrate until a crystal is precipitated; filtering, washing a filter cake using a polar solvent, and draining and drying under reduced pressure. By using the new refining method, the content of impurities in 5-fluorouracil may be reduced to less than 0.01%, the product purity is more than 99.98%, and the refining yield is higher than 70%. In addition, the refining method of the present invention has a simple process, convenient operation, low production costs, high product purity, a stable process, and is suitable for industrial production.
A 5-fluorouracil raw material or active pharmaceutical ingredient, comprising 5-fluorouracil with a weight percentage of 99.9% or more and impurities with a weight percentage of 0.05% or less, and the impurities are selected from 5-methoxyuracil, and dihydropyrimidine-2,4,5(3H)-trione;
A refining method for high-purity 5-fluorouracil, comprising the following steps:
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