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SPOSÓB WYTWARZANIA WYSOCE OCZYSZCZONEGO MATERIAŁU 68GE DO CELÓW RADIOFARMACEUTYCZNYCH
专利权人:
ITM Isotopen Technologien München AG
发明人:
JERNSTRÖM, JUSSI,ZHERNOSEKOV, KONSTANTIN,HARFENSTELLER, MARK,KELMENDI, NEVZAT
申请号:
PL17170482
公开号:
PL3401283T3
申请日:
2017.05.10
申请国别(地区):
PL
年份:
2020
代理人:
摘要:
The present invention relates to a method for the manufacture of highly purified 68 Ge material for radiopharmaceutical purposes. The invention particularly concerns the production of 68 Ge-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 68 Ge stock solution of commercial or other origin as raw material. Such 68 Ge 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 68 Ge from organic and metallic impurities with two different adsorbent materials. During the first separation phase 68 Ge is purified from both organic and metallic impurities by adsorption in germanium tetrachloride form, after which hydrolyzed 68 Ge is purified from remaining metallic impurities by cation exchange. The final 68 Ge-API-product e.g. fulfills the regulatory requirements for specifications of the GMP production of 68 Ge/ 68 Ga generators.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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