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<p>While prior research has predominantly focused on utilizing ultrasound to accelerate the precipitation of paclitaxel, this study uniquely investigates the integration of ultrasonic cavitation into fractional precipitation to optimize the efficiency of residual solvent removal from purified paclitaxel. The underlying mechanism reveals that increasing ultrasonic power (0–480 W) induces significant particle size reduction, thereby enlarging the specific surface area and accelerating solvent elution during the subsequent drying stage. Drying kinetics followed the Page model, with the methanol/water system demonstrating a higher drying rate constant than the acetone/water system. While 10&#xa0;min of ultrasonic irradiation was insufficient to meet regulatory standards, a 20-min treatment successfully reduced residual solvents to within ICH Q3C guidelines (acetone &lt; 5,000&#xa0;ppm; methanol &lt; 3,000&#xa0;ppm) under optimized conditions (480 W for methanol; 380–480 W for acetone). These results validate ultrasonic cavitation as a high-efficiency auxiliary process specifically for rigorous solvent elimination, offering a quantitative basis for enhancing energy efficiency and reducing costs in large-scale paclitaxel production.</p>

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Development of an Efficient Method for Removing Residual Solvents from Purified Paclitaxel by Ultrasound-Assisted Fractional Precipitation

  • 期刊论文

  • 发表日期：

    2026年6月23日

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  • Chaeyeon Lee,
  • Yeji Kang,
  • Min-Ju Yeon,
  • Jin-Hyun Kim

摘要

While prior research has predominantly focused on utilizing ultrasound to accelerate the precipitation of paclitaxel, this study uniquely investigates the integration of ultrasonic cavitation into fractional precipitation to optimize the efficiency of residual solvent removal from purified paclitaxel. The underlying mechanism reveals that increasing ultrasonic power (0–480 W) induces significant particle size reduction, thereby enlarging the specific surface area and accelerating solvent elution during the subsequent drying stage. Drying kinetics followed the Page model, with the methanol/water system demonstrating a higher drying rate constant than the acetone/water system. While 10 min of ultrasonic irradiation was insufficient to meet regulatory standards, a 20-min treatment successfully reduced residual solvents to within ICH Q3C guidelines (acetone < 5,000 ppm; methanol < 3,000 ppm) under optimized conditions (480 W for methanol; 380–480 W for acetone). These results validate ultrasonic cavitation as a high-efficiency auxiliary process specifically for rigorous solvent elimination, offering a quantitative basis for enhancing energy efficiency and reducing costs in large-scale paclitaxel production.