尿素14C胶囊中55Fe分析方法研究

为确保药品质量的可控性与安全性，需对尿素¹⁴C胶囊中的杂质核素⁵⁵Fe进行分析。本工作建立了尿素¹⁴C胶囊中⁵⁵Fe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⁵⁵Fe的活度，同时计算了尿素¹⁴C胶囊样品中放射性杂质核素⁵⁵Fe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⁵⁵Fe的活度限值为小于等于¹⁴C活度的0.1%、干扰核素¹⁴C的去污因子大于10⁵、铁的化学回收率在57%～67%之间、测量1 h的检测限为0.4 Bq。

Method for Determination of 55Fe in Urea 14C Capsule

⁵⁵Fe in urea ¹⁴C capsule should be analyzed, so that the controllability and safety of pharmaceutical can be guaranteed. An analysis method of ⁵⁵Fe was established for the urea ¹⁴C capsule. The method is that the samples are first purified twice by AGMP-1 anion exchange resin, and then ⁵⁵Fe is determined by liquid scintillation counter (LSC) and the limit value of impurity radionuclide ⁵⁵Fe in urea ¹⁴C 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 ⁵⁵Fe is less than or equal to 0.1% of the activity of ¹⁴C, the decontamination factor for ⁵⁵Fe with ¹⁴C is higher than 10⁵, the chemical recovery of Fe is 57%-67%, and the detection limit for 1 h is 0.4 Bq.