尿素14C胶囊中55Fe分析方法研究

Method for Determination of 55Fe in Urea 14C Capsule

  • 摘要: 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。

     

    Abstract: 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.

     

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