Method for producing fludarabin phosphate lithium, sodium, potassium, calcium and magnesium salts, purification method for producing fludarabin phosphate and fludarabin phosphate which is at least 99.5 % pure

摘要

Fludarabine phosphate (FAP) is purified by treating an aqueous solution of crude FAP with base, precipitating the obtained metal salt (I) of FAP with acetone and treating (I) with acid. Purification of fludarabine phosphate (FAP) involves: (i) dissolving crude FAP in water; (ii) treating the solution with alkali or alkaline earth metal base solution under stirring at less than 30[deg]C; (iii) slowly precipitating the solution in warm acetone at 45-55[deg]C; (iv) cooling, filtering off the precipitate and optionally drying to give a storage-stable lithium, sodium, potassium, calcium or magnesium salt (I) of FAP; (v) dissolving (I) in water; (vi) acidifying with mineral acid; and (vii) filtering off the precipitate and optionally drying. Independent claims are included for: (a) the preparation of (I) by steps (i)-(iv); (b) the preparation of FAP by preparing (I) as above then treating with mineral acid; and (c) FAP of purity at least 99.5% (preferably more than 99.85%). ACTIVITY : Cytotoxic. MECHANISM OF ACTION : None given.