Safety Monitoring

Research on quality control method of pharmaceutical excipient PEG 6000 based on the multivariate statistical analysis*

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  • 1. National & Local United Engineering Laboratory for TCM Advanced Manufacturing Technology, Tasly Pharmaceutical Co., Ltd., Tianjing 300410, China;
    2. China Pharmaceutical University, Nanjing 211198, China

Received date: 2020-02-25

  Online published: 2024-05-31

Abstract

Objective:Taking the compound Danshen dropping pills as an example,the PEG 6 000 quality control method. Methods:In this study,PEG6 000 was selected as the common used excipient.Firstly,the viscosity measurement method of PEG 6 000 suitable for the production conditions of dropping pills was established by rotary rheometer.Then,multivariable statistical analysis was carried out on the key attribute indexes such as average molecular weight,viscosity,condensation point and acidity.Fifteen batches of samples that met the requirements of compound Danshen dropping pills were used as the training set to establish the multi-variable statistical control chart. Results:12 batches of samples from different suppliers were selected as the validation set,and the accuracy of the model reached 100%,which could accurately distinguish whether PEG 6 000 met the production requirements of dropping pills. Conclusion:The method established in this study provides reference for pharmaceutical manufacturing enterprises to improve the abilities of excipients quality control and suppliers quality management.

Cite this article

XIONG Hao-shu, ZHANG Kai-xuan, LI Yao-yao, ZHAO Wan-shun, ZHANG Shun-nan, ZHU Yong-hong, YAN Kai-jing . Research on quality control method of pharmaceutical excipient PEG 6000 based on the multivariate statistical analysis*[J]. Chinese Journal of Pharmaceutical Analysis, 2021 , 41(2) : 329 -337 . DOI: 10.16155/j.0254-1793.2021.02.17

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