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Objective:To analyze the influencing factors of fluorescence method in determination of residual DNA in recombinant hep-atitis B vaccine bulk, and to evaluate the applicability of this method in hepatitis B vaccine control.Methods:According to the result of residual DNA in the bulk of hepatitis B vaccine determined by Digoxin-labeled DNA hybridization method, interference factors such as Tween-20, PEG and protein were explored.The linear range of the method, as well as accuracy and precision were evaluated for residual DNA determination in hepatitis B vaccine bulk.DNA standards from different sources were also investigated for their variance in labeling efficiency.Results: The linear range of fluorescence method was between 2.5 ~80 ng? mL -1 , which could be eliminated by phenol-chloroform extraction.Interference of protein was observed in determination of residual DNA by fluorescence method, with the recovery rate of about 90% and the coefficient of variation below 10%.Meanwhile, vari
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Objective:To analyze the influencing factors of fluorescence method in determination of residual DNA in recombinant hep-atitis B vaccine bulk, and to evaluate the applicability of this method in hepatitis B vaccine control.Methods:According to the result of residual DNA in the bulk of hepatitis B vaccine determined by Digoxin-labeled DNA hybridization method, interference factors such as Tween-20, PEG and protein were explored.The linear range of the method, as well as accuracy and precision were evaluated for residual DNA determination in hepatitis B vaccine bulk.DNA standards from different sources were also investigated for their variance in labeling efficiency.Results: The linear range of fluorescence method was between 2.5 ~80 ng? mL -1 , which could be eliminated by phenol-chloroform extraction.Interference of protein was observed in determination of residual DNA by fluorescence method, with the recovery rate of about 90% and the coefficient of variation below 10%.Meanwhile, vari
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