The First ICFE was held September 4～7, 1990 in Katholieke Universiteit Leuven, Belgium. The generalconference chairperson was C. Gorller-Walrand. The conference was sponsored by the Commission of theEuropean Communit...The First ICFE was held September 4～7, 1990 in Katholieke Universiteit Leuven, Belgium. The generalconference chairperson was C. Gorller-Walrand. The conference was sponsored by the Commission of theEuropean Communities. This conference has brought together chemists, physicists and other scientists in-volved in the fundamental and application research of f-elements from many countries. It was an importantinternational conference in series, held parallelly and alternatively with the northern american Rare EarthResearch Conference. In fact it was the third conference in Europe, inherited the International Rare EarthConference held in Zurich(1985)and International Conference on Lanthanides and Actinides held in Lisbon(1987). The international advisory committee of this conference included almost all the famous scientists of展开更多
氟[^(18)F]化钠注射液在合成过程中,可能因加速器引入的元素杂质和放射性核素杂质而影响产品质量。本文通过对比研究不同活度的氟[^(18)F]离子溶液在四甲基铵基阴离子交换(Quaternary Methyl Ammonium Cartridge,QMA)柱纯化前后样品中,...氟[^(18)F]化钠注射液在合成过程中,可能因加速器引入的元素杂质和放射性核素杂质而影响产品质量。本文通过对比研究不同活度的氟[^(18)F]离子溶液在四甲基铵基阴离子交换(Quaternary Methyl Ammonium Cartridge,QMA)柱纯化前后样品中,以及注射液产品中元素杂质和放射性核素杂质的变化情况,评估由加速器引入杂质在产品中的残留情况。研究发现,当加速器以金属铌(Nb)为靶腔、Havar膜为靶膜时,辐照过程中产生的元素杂质主要为钴(Co)、镍(Ni)、钼(Mo)等,同时检测到17种半衰期大于2 h的γ核素杂质,β衰变核素氚含量约为总活度的2×10^(-6)。经QMA柱及后续工艺纯化后,氟[^(18)F]化钠注射液中元素杂质水平显著降低,所有有害元素的含量均符合国际人用药品注册技术协调会元素杂质指导原则(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for Elemental Impurities,ICH Q3D)限度要求,放射性核纯度达到99.9999%以上,且未检出氚。研究结果表明,氟[^(18)F]化钠注射液经QMA柱及后续工艺纯化后能够有效清除和控制加速器引入杂质,可以有效保证产品的质量,保障临床用药安全,为氟[^(18)F]标记药物生产中的杂质控制研究提供了参考。展开更多
文摘The First ICFE was held September 4～7, 1990 in Katholieke Universiteit Leuven, Belgium. The generalconference chairperson was C. Gorller-Walrand. The conference was sponsored by the Commission of theEuropean Communities. This conference has brought together chemists, physicists and other scientists in-volved in the fundamental and application research of f-elements from many countries. It was an importantinternational conference in series, held parallelly and alternatively with the northern american Rare EarthResearch Conference. In fact it was the third conference in Europe, inherited the International Rare EarthConference held in Zurich(1985)and International Conference on Lanthanides and Actinides held in Lisbon(1987). The international advisory committee of this conference included almost all the famous scientists of
文摘氟[^(18)F]化钠注射液在合成过程中,可能因加速器引入的元素杂质和放射性核素杂质而影响产品质量。本文通过对比研究不同活度的氟[^(18)F]离子溶液在四甲基铵基阴离子交换(Quaternary Methyl Ammonium Cartridge,QMA)柱纯化前后样品中,以及注射液产品中元素杂质和放射性核素杂质的变化情况,评估由加速器引入杂质在产品中的残留情况。研究发现,当加速器以金属铌(Nb)为靶腔、Havar膜为靶膜时,辐照过程中产生的元素杂质主要为钴(Co)、镍(Ni)、钼(Mo)等,同时检测到17种半衰期大于2 h的γ核素杂质,β衰变核素氚含量约为总活度的2×10^(-6)。经QMA柱及后续工艺纯化后,氟[^(18)F]化钠注射液中元素杂质水平显著降低,所有有害元素的含量均符合国际人用药品注册技术协调会元素杂质指导原则(International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline for Elemental Impurities,ICH Q3D)限度要求,放射性核纯度达到99.9999%以上,且未检出氚。研究结果表明,氟[^(18)F]化钠注射液经QMA柱及后续工艺纯化后能够有效清除和控制加速器引入杂质,可以有效保证产品的质量,保障临床用药安全,为氟[^(18)F]标记药物生产中的杂质控制研究提供了参考。
