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Objective To establish a sodium deoxycholate (DOC) precipitation method for determination of free polysaccharide in group C meningococcal polysaccharide-tetanus toxoid conjugate vaccine (CPS-TT).Methods CPS and TT were treated by acid precipitation with DOC,and the optimum precipitation conditions to separate unconjugated and conjugated CPS were determined.The DOC precipitation method was validated.Results The optimum pH condition of the DOC precipitation method was 3.5.The results of 3 batches of CPS-TT determined by the DOC precipitation method showed that average content of TT in supernatant was 2.3 ％.The established method had better accuracy and precision,and the variation cofficients of intra-assay for 3 batches of CPS-TT were all ＜5％.Conclusion The DOC precipitation method can apply to quality control of group C meningococcal conjugate vaccine.
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Wang et al. (2014) studied this question.
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