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Study On The Synthesic Technologies And Quality Specification Of Febuxost

Posted on:2011-01-30Degree:MasterType:Thesis
Country:ChinaCandidate:L Y ZhaoFull Text:PDF
GTID:2131330338484757Subject:Drug analysis
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Febuxostat is known as a new inhibition of xanthine oxidase (XO). It is used to treat chronic hyperuricaemia in conditions where urate deposition has already occurred. Originally it was developed by Japanese Teijin Company, and was applicated in Japan in early 2004. The TAP Company has the application in the United States at the end of 2004, the French IPSEN company in Europe in August 2006. This is the first new drug applicating to treat hyperuricaemia in the past 40 years, which is efficacious better than the therapeutic drug-the golden gout Allopurinol. China is in the declaration clinical stage.The reported synthetic methods of Febuxostat were analyzed and discussed in this paper. The synthetic technology of Febuxostat was determined and established by small scale and optimization experiments, and it was completely feasible by large scale experiments. With the IR, MS, NMR and X-ray, its structure was characterized, which was according with the structure characteristics of Febuxostat.According to New durg (Chemicals durg) Research Guidance and the quality of research work in China pharmacopoeia (2005 Edsion) Vol, II Appendixâ…©â…¨A, methodological research of Febuxostat was studied, including as:identification, clarity and color of solution, related substance, and assay, etc. Experimental results about the relevant requirements of the drug were fit for the corresponding standards, which provided the proofs for evaluating the quality control in production and register stages.
Keywords/Search Tags:Febuxostat, Synthesis Technology, Quality Specification, Validation of Analytical Method
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