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LI Haoyu, TANG Baoqiang, HE Dongsheng, TU Jiasheng. Determination of residual impurities in pharmaceutical excipient cetomacrogol 1000 by gas chromatography[J]. Journal of China Pharmaceutical University, 2022, 53(3): 293-299. DOI: 10.11665/j.issn.1000-5048.20220306
Citation: LI Haoyu, TANG Baoqiang, HE Dongsheng, TU Jiasheng. Determination of residual impurities in pharmaceutical excipient cetomacrogol 1000 by gas chromatography[J]. Journal of China Pharmaceutical University, 2022, 53(3): 293-299. DOI: 10.11665/j.issn.1000-5048.20220306
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Determination of residual impurities in pharmaceutical excipient cetomacrogol 1000 by gas chromatography

  • 1.

    Center for Research Development and Evaluation of Pharmaceutical Excipients and Generic Drugs, School of Pharmacy, China Pharmaceutical University, Nanjing 210009

  • 2.

    National Medical Products Administration (NMPA) Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, Nanjing 210009, China

Funds: This study was supported by China National Key Hi-Tech Innovation Project for the R&D of Novel Drugs (No.2017ZX09101001-006-002) and the Drug Standard Establishment and Revision Project of Chinese Pharmacopoeia Commission (No.2020Y047)
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  • Received Date: January 05, 2022
  • Revised Date: May 13, 2022
    Graphical Abstract
    • Abstract
  • For the quality control of cetomacrogol 1000, a gas chromatographic method for the determination of residual impurities in cetomacrogol 1000, such as ethylene oxide, 1, 4-dioxane, ethylene glycol, diethylene glycol and triethylene glycol, was established and validated.The DB-1 column with headspace injection was used to detect ethylene oxide and 1, 4-dioxane with the inlet temperature of 150 °C, the FID temperature of 250 °C, the headspace equilibration temperature of 70 °C and the equilibration time of 45 min.The VF-17MS column with liquid injection was used to detect ethylene glycol, diethylene glycol and triethylene glycol with the inlet temperature of 270 °C, and the FID temperature of 290 °C.The results showed that ethylene oxide and 1,4-dioxane have a good linearity within their specified addition amount ranges (r > 0.999), with the RSD of precision of below 8.0% and the average recovery rates of 90.6% and 101.2%; and that ethylene glycol, diethylene glycol and triethylene glycol also have a good linearity between 3 ? 60 μg/mL (r > 0.999), with the RSD of precision of below 3.0%, and the recovery rates of 96% ~ 103%.The method established in this study has good specificity, linearity, precision and recovery rate, which can effectively detect the multi-component and trace impurities.
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    • References (13)
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