Effects of polysorbate 80 of different sources on the quality of docetaxel injection
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Abstract
This investigation was carried out for the quality comparison of ten kinds of polysorbate 80 from different sources according to Chinese Pharmacopoeia(ChP 2010)and evaluated the effect of polysorbate 80 on the quality of docetaxel injection.Docetaxel injections were prepared by solvent vacuum evaporation method,the content of docetaxel,individual impurity and total impurity content were chosen as the index,a comprehensive quality evaluation of docetaxel injection was conducted by desirability analysis.The results showed that polysorbate 80 from different sources had quality differences,and peroxide value of polysorbate 80 affected the quality of docetaxel injection.It should be emphasized that controlling the peroxide value of polysorbate 80 would be very important for qualified docetaxel injection.
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