大量[13N]氨的可靠生产系统,用于多次人体注射
Luis Michel Alonso Martinez1, Nabil Naim1, Alejandro Hernandez Saiz1
1Radiochemistry and Cyclotron Platform, Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), 900 Rue Saint Denis, Montréal, QC H2X 0A9, Canada.
Molecules (Basel, Switzerland)
|June 10, 2023
概括
一个新的半自动化工艺可靠地生产大量高纯度的用于正子发射断层扫描 (PET) 扫描. 这种高效的方法确保了符合cGMP的放射追踪器用于人类,支持超过1000名患者的成像程序.
科学领域:
- 放射化学 放射化学是指辐射化学.
- 核医学是一种核医学.
- 医疗成像医学成像
背景情况:
- [13N]氨是评估心肌输液和血液流动的重要阳离子发射断层扫描 (PET) 放射追踪器.
- 当前的生产方法可能是复杂和耗时的.
研究的目的:
- 开发和验证一个可靠的,半自动化过程,用于大规模的氨生产.
- 确保无线电追踪器符合人类使用的高纯度和监管标准.
主要方法:
- 在无菌条件下使用目标过程对水性乙醇溶液进行质子辐射.
- 简化生产系统,使用注射器驱动器和线内离子交换净化.
- 快速制造过程,从轰炸结束 (EOB) 开始,总生产和质量控制时间约为11分钟.
主要成果:
- 为[13N]氨生产实现了高的放射性化学产量 (~69 ± 3% n.d.c).
- 每天生产高达30GBq的高纯度,符合FDA/USP规格.
- 在四年内证明了可靠性,支持超过1000名患者的成像程序.
结论:
- 半自动化工艺提供了一种可靠,具有成本效益和高效的方法,用于符合cGMP标准的常规氨生产.
- 这种简化的系统有助于广泛使用[13N]氨用于心肌 perfusion 成像.
- 该过程易于操作和维护,使其适合临床环境.
相关概念视频
Preparation of Amines: Alkylation of Ammonia and Amines
3.5K
Alkylation is one of the methods used to prepare amines. Direct alkylation of ammonia or a primary amine with an alkyl halide gives polyalkylated amines along with a quaternary ammonium salt through successive SN2 reactions. This process of making the quaternary salt through the direct alkylation method is called exhaustive alkylation.
Each alkylation step makes the nitrogen center more nucleophilic, which triggers successive alkylations until a quaternary ammonium salt is formed. Considering...
Each alkylation step makes the nitrogen center more nucleophilic, which triggers successive alkylations until a quaternary ammonium salt is formed. Considering...
3.5K
2° Amines to N-Nitrosamines: Reaction with NaNO2
4.4K
Secondary amines react with nitrous acid to form N-nitrosamines, as depicted in Figure 1. Nitrous acid, a weak and unstable acid, is formed in situ from an aqueous solution of sodium nitrite and strong acids, such as hydrochloric acid or sulfuric acid, in cold conditions. In the presence of an acid, the nitrous acid gets protonated. The subsequent loss of water results in the formation of the electrophile known as nitrosonium ion.
4.4K
Preparation of 1° Amines: Gabriel Synthesis
3.6K
Direct alkylation is not a suitable method for synthesizing amines because it produces polyalkylated products. Gabriel synthesis is the most preferred method to exclusively make primary amines. The method uses phthalimide, which contains a protected form of nitrogen that participates in alkylation only once to predominantly give primary amines.
Strong bases like NaOH or KOH deprotonate the phthalimide to form the corresponding anion, which acts as a nucleophile. Further, the anion attacks an...
Strong bases like NaOH or KOH deprotonate the phthalimide to form the corresponding anion, which acts as a nucleophile. Further, the anion attacks an...
3.6K
Overview of Nitrogen Metabolism
8.2K
Nitrogen is a very important element for life because it is a major constituent of proteins and nucleic acids. It is a macronutrient, and in nature, it is recycled from organic compounds and stored in the form of ammonia, ammonium ions, nitrate, nitrite, or nitrogen gas by many metabolic processes. Many of these metabolic processes are carried out only by prokaryotes.
The largest pool of nitrogen available in the terrestrial ecosystem is gaseous nitrogen (N2) from the air, but this...
The largest pool of nitrogen available in the terrestrial ecosystem is gaseous nitrogen (N2) from the air, but this...
8.2K


