尿素14C胶囊中^(55)Fe分析方法研究

Method for Determination of^(55)Fe in Urea C Capsule

为确保药品质量的可控性与安全性,需对尿素^(14)C胶囊中的杂质核素^(55)Fe进行分析。本工作建立了尿素^(14)C胶囊中^(55)Fe分析测量方法,样品经过AGMP-1阴离子交换树脂2次分离纯化后,用液体闪烁计数器(LSC)测量^(55)Fe的活度,同时计算了尿素^(14)C胶囊样品中放射性杂质核素^(55)Fe的检测限,并对方法的专属性、耐用性和检测限进行了验证。结果表明,放射性杂质核素^(55)Fe的活度限值为小于等于^(14)C活度的0.1%、干扰核素^(14)C的去污因子大于10^(5)、铁的化学回收率在57%~67%之间、测量1 h的检测限为0.4 Bq。

^(55)Fe in urea^(14)C capsule should be analyzed,so that the controllability and safety of pharmaceutical can be guaranteed.An analysis method of^(55)Fe was established for the urea^(14)C capsule.The method is that the samples are first purified twice by AGMP-1 anion exchange resin,and then^(55)Fe is determined by liquid scintillation counter(LSC)and the limit value of impurity radionuclide^(55)Fe in urea^(14)C capsule is calculated,and the specificity,durability and detection limit of the method are verified.The results show that activity limit of the impurity radionuclide^(55)Fe is less than or equal to 0.1%of the activity of^(14)C,the decontamination factor for^(55)Fe with^(14)C is higher than 10^(5),the chemical recovery of Fe is 57%-67%,and the detection limit for 1 h is 0.4 Bq.