Method for the manufacture of highly purified 68Ge material for radiopharmaceutical purposes

A method for the manufacture of highly purified 68Ge material for radiopharmaceutical purposes. The invention particularly concerns the production of 68Ge-API (API=Active Pharmaceutical Ingredient) solution complying with the Guidelines for good manufacturing practices (GMP). Starting material for t...

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Bibliographische Detailangaben
Hauptverfasser:	Jernström, Jussi, Harfensteller, Mark, Kelmendi, Nevzat, Zhernosekov, Konstantin
Format:	Patent
Sprache:	eng
Schlagworte:	CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOIDCHEMISTRY CHEMISTRY COMPOUNDS CONTAINING METALS NOT COVERED BY SUBCLASSESC01D OR C01F CONVERSION OF CHEMICAL ELEMENTS INORGANIC CHEMISTRY METALLURGY NUCLEAR ENGINEERING NUCLEAR PHYSICS PERFORMING OPERATIONS PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL PHYSICS RADIOACTIVE SOURCES SEPARATION THEIR RELEVANT APPARATUS TRANSPORTING
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Beschreibung
Zusammenfassung:	A method for the manufacture of highly purified 68Ge material for radiopharmaceutical purposes. The invention particularly concerns the production of 68Ge-API (API=Active Pharmaceutical Ingredient) solution complying with the Guidelines for good manufacturing practices (GMP). Starting material for the method of the present invention can be a 68Ge stock solution of commercial or other origin as raw material. Such 68Ge containing raw solutions are purified from potential metal and organic impurities originating from production processes. The radiochemical method disclosed is based on a twofold separation of 68Ge from organic and metallic impurities with two different adsorbent materials. During the first separation phase 68Ge is purified from both organic and metallic impurities by adsorption in germanium tetrachloride form, after which hydrolyzed 68Ge is purified from remaining metallic impurities by cation exchange. The final 68Ge-API-product e.g. fulfills the regulatory requirements for specifications of the GMP production of 68Ge/68Ga generators.