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Details for Patent: 6,046,322

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Details for Patent: 6,046,322

Title: Process for the production of fludarabine-phosphate lithium, sodium, potassium, calcium and magnesium salts and purification process for the production of fludarabine-phosphate and fludarabine-phosphate with a purity of at least 99.5%
Abstract:A reduced temperature crystallization process for the obtaining fludarabine phosphate at a purity of at least 99.5%.
Inventor(s): Tilstam; Ulf (Berlin, DE), Schmitz; Thomas (Berlin, DE), Nickisch; Klaus (Berlin, DE)
Assignee: Schering Aktiengesellschaft (Berlin, DE)
Filing Date:Dec 10, 1998
Application Number:09/208,587
Claims:1. Process for the production of fludarabine-phosphate lithium, sodium, potassium, calcium and magnesium salts, whereby fludarabine-phosphate is dissolved in water, an alkali or alkaline-earth basic solution is added to this solution while being stirred and at temperatures of below 30.degree. C., and this solution is slowly poured into acetone that is 45-55.degree. C., cooled, and the deposited precipitate is optionally filtered and optionally dried.

2. Process for the production of fludarabine-phosphate, whereby the lithium, sodium, potassium, calcium and magnesium salts are produced according to claim 1 and then are released with mineral acid.

3. Process for the production of fludarabine-phosphate, whereby the lithium, sodium, potassium, calcium and magnesium salts are produced in a form that is more stable in storage according to claim 1 and then are released with mineral acid.

4. Process for the purification of fludarabine-phosphate, whereby crude fludarabine-phosphate is dissolved in water, an alkali or alkaline-earth basic solution is added to this solution while being stirred and at temperatures of below 30.degree. C., and this solution is slowly poured into acetone that is 45-55.degree. C., cooled, and the deposited precipitate is filtered and optionally dried and is obtained in a form that is stable in storage as a lithium, sodium, potassium, calcium or magnesium salt, and then this form that is stable in storage is dissolved in water and acidified with mineral acid, and the deposited precipitate is filtered and dried.
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