Asian Journal of Research In Chemistry
  • Year: 2012
  • Volume: 5
  • Issue: 3

Synthesis and characterization of novel impurities in Paroxetine Hydrochloride hemihydrate and adopting QbD principles to built in quality in process of final drug substance

  • Author:
  • Ramesh Yamgar, Sudhir Sawant
  • Total Page Count: 7
  • Page Number: 329 to 335

P. G. Dept of Chemistry, Govt. of Maharashtra's Ismail Yusuf College of Arts, Science and Commerce, Jogeshwari (East), Mumbai, 400 060, INDIA

*Corresponding Author E-mail: sawantsudhir@hotmail.com

Online published on 7 February, 2013.

Abstract

Synthesis of two novel impurities in the manufacturing process of Paroxetine.HCl. ½H2O is described. They were characterized by spectroscopic techniques like 1HNMR, 13CNMR and MS. Synthesis and reaction mechanism is also explained in details.

Keywords

Impurity synthesis and characterization, QbD, Environmental protection