Preparation of an oxaliplatin active substance, useful in the treatment of cancer and comprising a very low content of oxalic acid

摘要

Oxaliplatin active substance comprises oxalic acid (wt.%) (=0.8, preferably = 0.05, especially less than 0.02). An independent claim is included for the preparation of oxaliplatin active substance involving (a) Reacting potassium tetrachloroplatinate (K 2PtCl 4) with trans-l-1,2-cyclohexanediamine in an aqueous solution to obtain dichloro(trans-l-1,2-cyclohexanediamine)-platinum (II); (b) Adding silver nitrate (2 eq) to the product of step (A) to obtain diaquo(trans-l-1,2-cyclohexanediamine)-platinum (II); (c) Optionally adding potassium iodide or sodium iodide to the resulting solution, and adding active carbon under stirring; (d) Filtering and adding to the filtrate, alkali metal salt of oxalic acid, separating the oxaliplatin crystals formed by filtration and washing the crystals 2 - 5 times with water (pH 4.5 - 7); (e) Purifying oxaliplatin by recrystallisation to obtain crystals in a filter, where the crystals are washed 2 - 5 times with water (pH 4.5 - 7) to obtain the desired weight content of oxalic acid. ACTIVITY : Cytostatic. MECHANISM OF ACTION : None given.