초록 |
In this study, a drying method was developed for the effective removal of the residual solvents, methylene chloride and methanol, in purified paclitaxel. Residual methylene chloride was easily and conveniently removed below the ICH-specified value by rotary evaporation (~1 h) alone after pre-treatment of a sample (methylene chloride: 17,600 ppm) with 95% ethanol. In addition, residual ethanol (>14,300 ppm) met the ICH-Specified value (5000 ppm) after simple rotary evaporation (~1 h) alone with pre-treatment with water, and residual water also met the specified value(<4%) for active pharmaceutical ingredients. Acknowledgment This research was supported by Basic Science Research Program through the National Research Foundation of Korea(NRF) funded by the Ministry of Education, Science and Technology (Grant Number: 2015016271). |