HIGH PURITY ONDANSETRON HYDROCHLORIDE DIHYDRATE AND PROCESS FOR ITS SYNTHESIS

摘要

the object of the invention is ondansetron hydrochloride dihydrate (chemical name: 1,2,3,9 - tetrahydro - 9 - methyl - 3 - (2 - methyl imidazole -, lh - l - yl) methyl - 4 / - 4h - carbazole on hydrochloride dihydrate not more than 0,10% by mass), which contains the chemical pollution.the invention also fentitermu00e9k production procedure, according to which the base is known ku00e9miaiszintu00e9zissel produced ondansetron (impurity content: 0.5 to 10 mass; color: dark brown, the szu00fcrku00e9tu0151l 95 - 100 degrees celsius) in water - onsu00f3sav solution treated, the solution ph value of 5.8 to 6.2 by the temperature of the solution, majdugyanezen are clarified, the szennyezu00e9seketszu0171ru00e9ssel removedthe obtained filtrate to ph value of 1 to 2 u00e1llu00edtju00e1kvizes su00f3savoldattal and the solution 0,1 - 1 oc / min cooling sebessu00e9ggel20 - 25 oc chilled by crystallisation, received the desired termu00e9ketizolu00e1lju00e1k, oh.