GENOTOXIC IMPURITIES AND IMPURITY PROFILING OF PHARMACEUTICAL DRUG SUBSTANCES

Abstract

The significance of drugs and their safety is based on their therapeutic use. In the context of pharmaceutical drugs and their effect caused by the presence of impurities. The drug safety and its toxicological profile have first been evaluated and further allowed for bulk formulations. The unrequired impurities of drug formations have controlled the drug effect when it is allowed for administration into the body and their continuous toxicological concern effect. Moreover, the impurities of drugs should be completely evaluated before entering the market. The formulations are significantly confident by the extreme monitoring of impurities during their process. However, the effect of impurity analysis on the drugs is based on the instruments being used. Therefore, in drug analysis analytical
activities plays a crucial role in the pharmaceutical industries. The recent literature is quite global for this concern in Pharmacopoeias. It is very essential part of purity and impurity profiling for regulatory agencies. Impurities are considered like organic material and are
the inner part of drug substance raised part of pharmaceutical drug synthesis. So, this article discusses impurity profiling of pharmaceutical drug substances and genotoxic impurities.