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Received September 7, 2019
Accepted October 20, 2019
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Removal of residual chloroform from amorphous paclitaxel pretreated by alcohol
Department of Chemical Engineering, Kongju National University, Cheonan 31080, Korea
Korean Journal of Chemical Engineering, December 2019, 36(12), 1965-1970(6), 10.1007/s11814-019-0413-9
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Abstract
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.
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Kang HJ, Kim JH, Biotechnol. Bioproc. Eng., 24, 513 (2019)
Pyo SH, Choi HJ, Han BH, J. Chromatogr. A, 1123, 15 (2006)
Lee CG, Kim JH, Process Biochem., 59, 216 (2017)
Yoo KW, Kim JH, Biotechnol. Bioproc. Eng., 23, 532 (2018)
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Kim JH, Korean Chem. Eng. Res., 56(3), 430 (2018)
Yoon JW, Kim JH, Korean J. Chem. Eng., 28(9), 1918 (2011)
Kawabata Y, Wada K, Nakatani M, Yamada S, Onoue S, Int. J. Pharm., 420, 1 (2011)
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)
Liggins R, Hunter W, Burt M, J. Pharm. Sci., 86, 1458 (1997)
Jang WS, Kim JH, Biotechnol. Bioproc. Eng., 24, 529 (2019)
ICH guidance Q3C impurities: Residual solvents, Fed. Regist., 62, 67377 (1997).
Choi MG, Kim JH, Korean J. Chem. Eng., 34(12), 3041 (2017)
Lee CG, Kim JH, Process Biochem., 50(6), 1031 (2015)
Lee JY, Kim JH, Process Biochem., 48(11), 1809 (2013)
Han JH, Ji SB, Kim YS, Lee SH, Park SH, Kim JH, Korean Chem. Eng. Res., 55(6), 807 (2017)
Kim YS, Kim JH, J. Chem. Thermodyn., 130, 104 (2019)
Hancock B, Parks M, Pharm. Res., 17, 397 (2000)
Gupta S, Rafiq S, Kundu M, Sen P, J. Phys. Chem. B, 116(4), 1345 (2012)
Kamath G, Georgiev G, Potoff JJ, J. Phys. Chem. B, 109(41), 19463 (2005)
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Ngoc N, Takaomi K, Ultrason. Sonochem., 17, 186 (2010)
Venegas-Sanchez JA, Tagaya M, Kobayashi T, Ultrason. Sonochem., 21, 295 (2014)
