注射用泮托拉唑钠细菌内毒素检查方法的建立

Establishment of bacterial endotoxin test of pantoprazole sodium for injection

目的建立注射用泮托拉唑钠细菌内毒素检查方法。方法按《中国药典》2005年版二部附录细菌内毒素检查法,对不同批号的样品进行了干扰试验和细菌内毒素检查。结果注射用泮托拉唑钠水溶液对TAL与细菌内毒素的凝集反应有干扰作用,经稀释后可排除干扰。结论本品不干扰浓度为2 mg/ml可采用细菌内毒素检查法进行质量控制。

Objective To establish a method for bacterial endotoxin test of pantoprazole sodium for injection. Methods According to appendix of＆quot;Chinese pharmacopoeia＆quot;2005 edition, the interference test and bacterial endotoxin test of different batches of samples were carried out. Results There was interference in the agglutinate reaction between the sample and the relative TAL with pantoprazole Sodium for Injection, and the interference was eliminated after diluted. Conclusion The noninterference concentration of pantoprazole sodium for injection is 2 mg/ml. The bacterial endotoxin test can be used for the quality control of pantoprazole sodium for injection.