Use of RCX-10 for Analysis of [18F]FDG
[18F]FDG 在醫療影像中的重要性
[18F]FDG（2-[18F]氟-2-去氧-D-葡萄糖）是目前臨床上最常用的放射性示蹤劑，用於正子斷層攝影（PET）。其成像原理依靠 Warburg effect，也就是腫瘤或發炎組織會有更高的葡萄糖攝取量。
因此，[18F]FDG 在癌症診斷、分期、再分期中應用非常廣泛，包括肺癌、大腸癌、淋巴瘤、黑色素瘤、頭頸癌、腦癌與乳癌。此外，它也被廣泛用於心臟、肺部及腦部的代謝研究。
為何需要快速可靠的分析方法
由於 18F 核素的半衰期僅有 109.8 分鐘，[18F]FDG 這類放射藥物通常必須 就地生產 或在短距離內運輸。隨著臨床需求增加，許多醫院自行設置迴旋加速器與合成設施。
在產品釋放至臨床使用前，每一批 [18F]FDG 都必須進行化學與放射化學純度檢測，以符合藥典（USP 與 EP）的嚴格規範。這對品質控管（QC）提出了快速、可靠的檢測需求。
RCX-10 色譜柱的分析優勢
Hamilton 的 RCX-10 陰離子交換色譜柱，提供了一種快速而可靠的 HPLC 方法：
- 在 15 分鐘內完成分析，效率高。
- 具備優良的色譜分離表現，能有效區分 [18F]FDG 與雜質。
- 方法符合 USP（美國藥典） 與 EP（歐洲藥典） 規範。
- 適用於臨床日常的品質控管（Routine QC）。
其分離機制是透過強鹼性流動相，使弱酸性糖類形成陰離子，並被 RCX-10 柱內的帶正電樹脂（季銨鹽）吸附，實現高效分離。
實驗方法與應用
傳統的藥典方法採用 高效陰離子交換層析（HPAEC） 搭配 脈衝安培檢測器（PAD） 與放射檢測器。Hamilton 提供的 RCX-10 色譜柱，能在等度條件下完成此類分析，幫助實驗室快速獲得結果。
這讓醫院與放射藥物合成單位能更快完成品質控管，確保 PET 放射性藥物的安全性與可靠性。
結論
RCX-10 色譜柱為 [18F]FDG 提供了一個 快速、準確且符合國際藥典規範 的分析解決方案。在 PET 影像與放射性藥物 QC 領域，這是一個值得信賴的日常分析工具。
Use of RCX-10 for Analysis of [18F]FDG
Importance of [18F]FDG in Medical Imaging
[18F]FDG (2-[18F]fluoro-2-deoxy-D-glucose) is the most widely used radiotracer for positron emission tomography (PET). Its imaging principle is based on the Warburg effect, where tumors and inflamed tissues show increased glucose uptake.
Therefore, [18F]FDG is extensively applied in the diagnosis, staging, and restaging of cancers such as lung, colorectal, lymphoma, melanoma, head and neck, brain, and breast cancer. Beyond oncology, it is also widely used in metabolic studies of the heart, lungs, and brain.
Why a Fast and Reliable Method is Needed
The 18F radionuclide has a short half-life of only 109.8 minutes, meaning radiopharmaceuticals like [18F]FDG must be produced locally or transported over short distances. With increasing clinical demand, many hospitals have established their own cyclotrons and synthesis facilities.
Before clinical release, each batch of [18F]FDG must undergo chemical and radiochemical purity testing in strict accordance with USP and EP guidelines, creating the need for fast and reliable QC methods.
Advantages of the RCX-10 Column
Hamilton’s RCX-10 anion-exchange column provides a fast and reliable HPLC method:
- Analysis completed within 15 minutes, ensuring efficiency.
- Excellent chromatographic separation of [18F]FDG and impurities.
- Compliant with USP and EP pharmacopeial standards.
- Suitable for routine clinical quality control (QC).
The separation principle relies on a strongly basic mobile phase, converting weakly acidic sugars into anions that are retained on the positively charged quaternary ammonium resin within the RCX-10 column.
Methodology and Applications
Compendial methods typically use High-Performance Anion-Exchange Chromatography (HPAEC) with Pulsed Amperometric Detection (PAD) and a radioactivity detector. Hamilton’s RCX-10 column enables such analyses under isocratic conditions, delivering quick and reliable results.
This allows hospitals and radiopharmaceutical facilities to perform faster QC and ensure the safety and reliability of PET drugs.
Conclusion
The RCX-10 column provides a fast, accurate, and pharmacopeia-compliant solution for [18F]FDG analysis. In PET imaging and radiopharmaceutical QC, it stands as a reliable daily analytical tool.