关键词: 碘［¹³¹I］爱克妥昔单抗注射液, 细菌内毒素检查, 干扰实验

Abstract:

To establish a method for the bacterial endotoxin test of Iodine ［¹³¹I］ Actuximab Injection,The experiment was carried out according to the appendix ⅪE in Vol.Ⅱ of the 2010 version of Chinese Pharmacopoeia. The results demonstrated that the preparation interfered with the test at 10 times, 20 times and 40 times dilution,and the interference can be eliminated after the sample was diluted to 80 times or the sample was diluted to 20 times with the endotoxin-specific buffer dissolving the Tachypleus Amebocyte Lysate. Two methods can be used to test the bacterial endotoxin of Iodine［ ¹³¹I］ Actuximab Injection. One is the sample should be diluted to atleast 80 times,the other is the sample was diluted to 20 times with the endotoxin-specific buffer dissolving the Tachypleus Amebocyte Lysate. The dilution method is the preferred method for the quality control.

Key words: iodine ［¹³¹I］ actuximab injection, bacterial endotoxin test, interference test