Impurity Profile Study of Venlafaxine Hydrochloride, an Antipsychotic Drug Substance

Abstract

Venlafaxine hydrochloride is a phenyl ethylamine derivative, used for the treatment of depression. During the process development of venlafaxine hydrochloride, six process-related potential impurities were detected in high-performance liquid chromatography. All these impurities were identified, synthesized, and subsequently characterized by their respective spectral data (IR, mass, ¹H NMR, and ¹³C NMR) as described in this article.

Keywords:

• Antipsychotic
• depression
• potential impurities
• venlafaxine

ACKNOWLEDGMENTs

The authors are thankful to the management of Dr. Reddy's Laboratories Limited and the colleagues in the Research and Development division for their constant encouragement and excellent cooperation.

Notes

IPDO-IPM Communication No. 00096.