| Paclitaxel is a kind of diterpenoid compound insoluble in water.It is a typical antimicrotubule drug and has obvious active anticancer against many kinds of malignant tumors.Paclitaxel injection is the standard treatment regimen recommended by the2013 NCCN(National Comprehensive Cancer Network)guidelines for breast cancer,ovarian cancer and non-small cell lung cancer,and its safety has been receiving much attention.This paper is mainly focus on the source of unknown impurities,impurity stability and impurity qualitative study of large content found in paclitaxel injection.The structure of the paper is as follows:Verification of source of unknown impurities.The source of the impurities was tested by high performance liquid chromatography(HPLC),and 3 unknown impurities were found to be high in Taxol ?(Paclitaxel for Injection).The three unknown impurities were all introduced by Polyoxyl 35 Castor Oil through single and multiple comparative studies on the excipients in the process formula.Unknown Impurity Stability Study: The oxidation and heating damage of Polyoxyl35 Castor Oil were studied.After 10 days’ study,it was found that the content of 3 kinds of impurities increased under the conditions of heating and oxidation,thus,3 kinds of unknown impurities were unstable under the conditions of oxidation and heating.Qualitative study of unknown impurities.The structure of the unknown impurities was inferred by the method of liquid mass spectrometry(LC-MS),and the three unknown impurities were confirmed to be the process products introduced in the production of Polyoxyl 35 Castor Oil.Through the above study,the sources of three unknown impurities were confirmed and suggestions were put forward for the storage conditions and methods of Polyoxyl35 Castor Oil to control the increase of the content of the three impurities,and the process flow of paclitaxel injection were further optimized to reduce the content of the three impurities in the production process of paclitaxel injection. |
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