Experimental Evaluation of Genotoxic Impurity in Risedronate by Gas Chromatography

Jadhav Deepak Ramakant, Dr. Kailas Narayan Sonune

Volume 5, Issue 3 2021

Page: 16-22

Abstract

The pharmaceutical industry is expanding daily with the goal of creating new therapeutic compounds through chemical synthesis or from natural sources, but one crucial feature has never changed: the product must be as pure in terms of quality as possible. Therefore, purity has always been regarded as a crucial component in ensuring the quality of any pharmaceutical medicinal material or drug product. It is essential that such products are safe, effective, and of good quality as these are directly consumed by human beings. There is no drug in the world that is not harmful or even poisonous at high doses. The quality of a drug substance or drug product is impacted by the presence of contaminants. Genotoxicity is a word used to describe any adverse change to the genetic code, independent of the process that caused the change. Genotoxicity, as used in genetics, refers to a feature of chemical agents that alters the genetic material in a cell, resulting in mutations that may cause cancer. The objective of this work is to create a simple gas chromatographic analytical method for the detection of morphine and thiomorpholide in risedronate sodium at trace levels.

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