A Review: Recent Trends in Analytical Techniques for Characterization and Structure Elucidation of Impurities in the Drug Substances

Abstract

Parmar et al.: Recent Analytical Techniques for Characterization of ImpuritiesImpurity is an unwanted substance present in the active pharmaceutical ingredients that form during the synthesis process of active pharmaceutical ingredients or any unwanted constituent that is produced besides the active ingredient during the formulation or the aging of active pharmaceutical ingredients. Even the insignificant quantity of impurity existing in the medicinal product may harm the patient life and compromises the purity and superiority of the medicinal product. According to International council for harmonisation guidelines, analytical monitoring of impurity is a prerequisite and mandatory requirement for approval of market authorization of the new drug substance. Any pharmaceutical product would be capable to serve their intended therapeutic activity when they are free from impurity. Thus, an impurity existing in an active pharmaceutical ingredient needs to be identified and quantify with the help of modern analytical approaches. This review explores the basic information concerning impurity profiling, highlights the advantages of an analytical technique and also focuses on the limitation of different analytical methods for impurity profiling with possible ways to overcome the limitation.

Structure Identification and Risk Assurance of Unknown Impurities in Pramipexole Oral Drug Formulation

“…Tese unwanted components other than API and excipients are known as impurities. Impurity is the product or substance formed in the synthesis, including intermediate or the side product of intermediate that formed during the side reaction or unwanted chemical reaction [5][6][7][8].…”

Molecularly Imprinted Polymers for Pharmaceutical Impurities: Design and Synthesis Methods

“…According to the ICH, impurities are not active ingredients or excipients of drug products [ 4 ]. Impurities are classified as organic compounds, residual solvents, and inorganic impurities ( Figure 1 ) [ 1 , 5 ]. Impurities can result from chemical changes in drug substances during drug product manufacturing and storage due to light, temperature, pH, water, and reactions with excipients [ 4 ].…”