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PROCÉDÉ DE FABRICATION DE MATÉRIAU 68GE HAUTEMENT PURIFIÉ À DES FINS RADIOPHARMACEUTIQUES
专利权人:
ITM Isotopen Technologien München AG
发明人:
申请号:
EP17170482.8
公开号:
EP3401283A1
申请日:
2017.05.10
申请国别(地区):
EP
年份:
2018
代理人:
摘要:
The present invention relates to 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.
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中国工程科技知识中心
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