Pharmaceutical impurities: A review of their importance in drug safety and efficacy

Abstract

In the field of pharmaceutical chemistry, impurities are considered as unwanted chemicals that present in the therapeutically active pharmaceutical compounds (API). They are unusually potent and expected to produce toxicity and reactivity; hence it may be shows unexpected pharmacological actions which are harmful to human health. The control of impurities is currently a critical issue to the pharmaceutical industry. The most possible source of impurities is the synthesis that involves various steps, i.e. from starting materials to finished products through the intermediate steps. Impurities in drug substances and drug products are critical issues in the generic drugs and have significant impact on the approvals of drugs hence International Conference on Harmonization (ICH) and Food and Drug Administration (FDA) guidelines introduce the identification and qualification procedures for them, by using various analytical techniques like TLC, LC, GC, MS, LCNMR, IR, UV, GC-MS, LC-MS, NMR etc.