【摘要】 目的确定细菌内毒素检查法中,供试品溶液的pH对细菌内毒素检查法检测结果的影响。方法用2005年版《中国药典》二部中规定的细菌内毒素检查方法及干扰试验方法进行试验。结果供试品溶液的pH在4~10内时,一般不会对细菌内毒素检查检测结果产生较大影响;当供试液的pH<4或>10时,会增加细菌内毒素假阴性结果出现的几率。结论供试液的pH大小会对细菌内毒素检测结果产生较大影响。更多还原

【Abstract】 OBJECTIVE To confirm the effect of pH value of sample solution on bacterial endotoxin test.METHODS The effect of pH was evaluated by bacterial endotoxin test and interference test of ChP2005.VolⅡ.RESULTS The bacterial endotoxin test wasn′t interfered at pH range of 4~10. Whereas false negative probability was incrfeased out of pH rang of 4~10.CONCLUSION The results of bacterial endotoxin test are affected by the pH value of sample solutions.更多还原