Relation of polysorbate 80 quality to the sensitization

This investigation carried out quality inspection items of four kinds of polysorbate 80 of different sources according to the European Pharmacopoeia（EP 5.4） and fitted the results in order to obtain the overall quality index .The sensitivity tests using guinea-pig allowed the comparison of the minimum sensitizing dose and the extent of anaphylactoid reaction of the polysorbate 80.The results showed that the overall quality index and the minimum sensitizing dose was positively correlated，while the overall quality index and the extent of anaphylactoid reaction was negatively correlated，indicating that the quality and sensitization of polysorbate 80 is closely related.