Robbins P J
Am J Hosp Pharm. 1983 Apr;40(4):629-33.
The reliability and reproducibility of five miniature chromatography systems for the radiochemical purity of 99mTc-labeled technetium Tc 99m pentetate was evaluated. Radiochemical purity of technetium Tc 99m pentetate was determined 15-30 minutes after preparation once a month for nine consecutive months. A reference value was determined by gel filtration or by conventional-length paper chromatography and thin-layer chromatography. Radiochemical purity was determined simultaneously by five miniature chromatography systems. The miniature systems included an in-house system and commercial systems distributed by Ackerman Nuclear, Ashley Innovations, Atomic Products, and Technical Advancement. Each miniature system was tested in duplicate. A follow-up comparison of the Ackerman Nuclear and in-house systems was performed for an additional nine months. Labeling efficiency by the reference method was greater than 97% for all nine months. The miniature systems gave results that were comparable in most months. Very low labeling efficiency occurred with the Ackerman Nuclear system in month 9. The follow-up comparison produced only one unconfirmed result for the Ackerman Nuclear system that would have caused a laboratory to erroneously discard a batch of technetium Tc 99m pentetate. The miniature chromatography systems evaluated generally will give reliable and reproducible results for the radiochemical purity of technetium Tc 99m pentetate for nine months after receipt of the systems.
评估了五种微型色谱系统用于测定99mTc标记的锝[99mTc]喷替酸盐放射化学纯度的可靠性和可重复性。连续九个月,每月制备一次锝[99mTc]喷替酸盐,在制备后15 - 30分钟测定其放射化学纯度。通过凝胶过滤或常规长度的纸色谱法和薄层色谱法确定参考值。同时用五种微型色谱系统测定放射化学纯度。微型系统包括一个内部系统以及由阿克曼核能公司、阿什利创新公司、原子产品公司和技术进步公司经销的商业系统。每个微型系统均进行了两次测试。对阿克曼核能公司的系统和内部系统又进行了九个月的后续比较。在全部九个月中,参考方法的标记效率均大于97%。在大多数月份里,微型系统给出的结果具有可比性。在第9个月,阿克曼核能公司的系统出现了非常低的标记效率。后续比较中,阿克曼核能公司的系统仅产生了一个未经证实的结果,该结果可能会导致实验室错误地废弃一批锝[99mTc]喷替酸盐。所评估的微型色谱系统通常在收到系统后的九个月内,对于锝[99mTc]喷替酸盐的放射化学纯度能给出可靠且可重复的结果。