ABSTRACT

Impurity is something that is impure. A substance of interest mixed or impregnated with an extraneous or usually inferior substance, from the standpoint of its usage, the drug substance is compromised in terms of purity even if it contains another material with superior pharmacological or toxicological properties. Impurity profiling has gained importance in modern pharmaceutical analysis due to the fact that unidentified, potentially toxic impurities are hazardous to health and in order to increase the safety of drug therapy, impurities should be identified and determined by selective methods. Terms such as residual solvents, by product, transformation products, degradation products, interaction products and related products are frequently used to define impurities. Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. There are different methods for detecting and characterizing impurities with TLC, HPLC, HPTLC, etc. Impurity profiling study has been in the limelight in the recent pharmaceutical scenario and its importance is increasing day-by-day. The present review covers various aspects related to the analytical method development for impurity profiling of Active Pharmaceutical ingredient and pharmaceutical products. Key words: Gas chromatography, HPLC, ICH guidlines
Publication date: 01/04/2022

https://ijbpas.com/pdf/2022/April/MS_IJBPAS_2022_5998.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.4.5998