PROCESS FOR PREPARING PHARMACEUTICAL-GRADE NEUTRAL PLATINUM (II) ANTINEOPLASTIC DERIVATIVES HAVING LOW SILVER CONTENT

摘要

A process for preparing pharmaceutical-grade neutral platinum (II) antineoplastic derivatives having a silver content less than or equal to 3 ppm, the process comprising: provision of a weighed quantity of Pt (II) cis-diiodide complex; titration of a sample of the Pt (II) cis-diiodide complex with a silver solution to determine the stoichiometric quantity of silver necessary to make said Pt (II) cis-diiodide complex react; addition to the Pt (II) cis-diiodide complex of a stoichiometric quantity of silver solution, allowing it to react with stirring, and decanting; determination of the presence of residual silver in the supernatant; optional addition of Pt (II) cis-diiodide complex to neutralise any residual silver ions detected; filtration to remove solid silver iodide and addition to the filtrate of an aqueous solution of ligand. A pharmaceutical-grade neutral platinum (II) antineoplastic derivative having a silver content less than or equal to 3 ppm obtainable by the aforementioned process.