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

Ramesh Yamgar; Sudhir Sawant

Journal :   Asian Journal of Research in Chemistry

Volume No. :   5

Issue No. :  3

Year :  2012

Pages :   329-335

ISSN Print :  0974-4169

ISSN Online :  0974-4150

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

Ramesh Yamgar, Sudhir Sawant

sawantsudhir@hotmail.com

Address:

Ramesh Yamgar and Sudhir Sawant*
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

DOI No:

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.

Cite:

Ramesh Yamgar, Sudhir Sawant. Synthesis and characterization of novel impurities in Paroxetine Hydrochloride hemihydrate and adopting QbD principles to built in quality in process of final drug substance. Asian J. Research Chem. 5(3): March 2012; Page 329-335.

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