Study Of Stress Induced Degradation In Anticancer Drugs Lcms MS Analysis And Stability Indicating HPLC Method Development

Abstract

Drug formulations contain active pharmaceutical ingredients (APIs) and excipients. APIs present in the formulations contain some undesired impurity, which affects purity of the APIs. Therefore, along with % purity, impurity profiling is also needed to be carried out of all the APIs. Impurity profiling describes the account or description of maximum possible types of identified or unidentified impurities present in any APIs. These impurities can be API related impurities, process related impurities or stability related impurities. API related impurities include stereochemistry, crystallization, and functional group of APIs. Process related impurities include chemicals, reagents, catalysts, residual solvents, synthetic intermediate products, by product, degradation products, method conditions related impurities, and formulation related impurities. newline