Issue
Korean Journal of Chemical Engineering,
Vol.36, No.12, 1965-1970, 2019
Removal of residual chloroform from amorphous paclitaxel pretreated by alcohol
A drying method that can effectively remove residual solvents from chloroform-induced amorphous paclitaxel was developed. Simple rotary evaporation with alcohol (methanol or ethanol) pretreatment was sufficient to remove residual chloroform and alcohol concentrations below the ICH limits (60 ppm for chloroform, 3,000 ppm for methanol, and 5,000 ppm for ethanol). In addition, SEM analysis and ultrasonic treatment showed that residual solvent removal is related to the porous structure of the sample due to the high vapor pressure of the chloroform-alcohol mixture and the hydrogen bonding between chloroform and alcohol.
[References]
  1. Lee SH, Kim JH, Process Biochem., 76, 187, 2019
  2. Kang HJ, Kim JH, Biotechnol. Bioproc. Eng., 24, 513, 2019
  3. Pyo SH, Choi HJ, Han BH, J. Chromatogr. A, 1123, 15, 2006
  4. Lee CG, Kim JH, Process Biochem., 59, 216, 2017
  5. Yoo KW, Kim JH, Biotechnol. Bioproc. Eng., 23, 532, 2018
  6. Kim HS, Kim JH, Process Biochem., 56, 163, 2017
  7. Kim JH, Korean Chem. Eng. Res., 56(3), 430, 2018
  8. Yoon JW, Kim JH, Korean J. Chem. Eng., 28(9), 1918, 2011
  9. Kawabata Y, Wada K, Nakatani M, Yamada S, Onoue S, Int. J. Pharm., 420, 1, 2011
  10. Khadka P, Ro J, Kim H, Kim I, Kim JT, Kim H, Cho JM, Yun G, Lee J, Asian J. Pharm. Sci., 9, 304, 2014
  11. Liggins R, Hunter W, Burt M, J. Pharm. Sci., 86, 1458, 1997
  12. Jang WS, Kim JH, Biotechnol. Bioproc. Eng., 24, 529, 2019
  13. ICH guidance Q3C impurities: Residual solvents, Fed. Regist., 62, 67377 (1997).
  14. Choi MG, Kim JH, Korean J. Chem. Eng., 34(12), 3041, 2017
  15. Lee CG, Kim JH, Process Biochem., 50(6), 1031, 2015
  16. Lee JY, Kim JH, Process Biochem., 48(11), 1809, 2013
  17. Han JH, Ji SB, Kim YS, Lee SH, Park SH, Kim JH, Korean Chem. Eng. Res., 55(6), 807, 2017
  18. Kim YS, Kim JH, J. Chem. Thermodyn., 130, 104, 2019
  19. Hancock B, Parks M, Pharm. Res., 17, 397, 2000
  20. Gupta S, Rafiq S, Kundu M, Sen P, J. Phys. Chem. B, 116(4), 1345, 2012
  21. Kamath G, Georgiev G, Potoff JJ, J. Phys. Chem. B, 109(41), 19463, 2005
  22. Singh P, Sharma B, Sidhu K, Can. J. Chem., 57, 387, 1979
  23. Ngoc N, Takaomi K, Ultrason. Sonochem., 17, 186, 2010
  24. Venegas-Sanchez JA, Tagaya M, Kobayashi T, Ultrason. Sonochem., 21, 295, 2014