An Overview on Scientific Approaches for Impurity Profiling In New Pharmaceutical Substances and Products- A Review Article

In the pharmaceutical world, an impurity is considered as any other organic material, besides the drug substance, or ingredients, arise out of synthesis or unwanted chemicals that remains with API’s. Impurity profiling is the process of acquiring and evaluating data that establishes biological safety of an individual impurity; thus, revealing its need and scope in pharmaceutical research. The control of impurities is currently a critical issue to the pharmaceutical industry. The control of impurities in Formulated products and Active Pharmaceutical ingredient’s were regulated by various regulatory authorities like US-FDA, ICH, MHRA, TGA etc. As per International Conference on Harmonization guidelines, the Impurity may be defined as any component of new drug product that is not the drug substance or an excipient in drug product. 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. The present review covers various aspects related to the analytical methods for impurity profiling of an active pharmaceutical ingredient.