Determination of bacterial endotoxin in paclitaxel injection by dynamic chromogenic method detection method research
Objective To establish a method for the determination of bacterial endotoxin in paclitaxel injection by dynamic chromogenic method.Methods According to the requirements of bacterial endotoxin test method in the fourth General Rule 1143 of the 2020 edition of Pharmacopoeia of the People's Republic of China,A photometric method for the determination of bacterial endotoxin in Paclitaxel Injection was studied and developed on Epoch 2 NS.The effective dilution factor was determined by reliability test of limulus agent and interference test pre-experiment of micro-dynamic chromogenic method.Then three batches of paclitaxel injection were taken for interference test,the recovery rate was determined,and bacterial endotoxin was detected.Results In the reliability test of standard curve,the correlation coefficients of limulus agent standard curve|r|are greater than 0.980.When the test product was diluted 150,300,450 times,there was no interference to the determination.Three batches of samples were used for interference tests with limulus reagents from two manufacturers respectively.The recoveries were in the range of 50%-200%.The results of bacterial endotoxin in three batches of samples were all below the limit value.Conclusion Micro-dynamic chromogenic method can be used for quantitative determination of bacterial endotoxin in paclitaxel injection.
Paclitaxel InjectionBacterial endotoxinsMicro-dynamic chromogenic methodInterference test
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