PHARMACEUTICAL IMPURITIES: A MULTIFACETED REVIEW OF ORIGINS, CLASSIFICATION, ANALYSIS AND CONTROL

Kavya V.*, Kawaljeeth Singh, Kavyashree S. B., Bhagyashree K. C. and Vedashree M.

ABSTRACT

Pharmaceutical impurities pose significant challenges to drug safety, efficacy, and quality. This comprehensive review provides an in-depth examination of the origin, classification, analysis, and control of pharmaceutical impurities. We discuss the sources of impurities, including synthetic pathways, degradation products, and contaminants, and classify them based on their chemical nature. Various analytical techniques for detecting and quantifying impurities are reviewed, including chromatography, spectroscopy, and mass spectrometry. Additionally, we explore regulatory guidelines and strategies for controlling impurities in pharmaceutical products. This review aims to provide a thorough understanding of pharmaceutical impurities, enabling researchers and industry professionals to develop effective methods for minimizing their impact on drug development and ensuring the safety of pharmaceutical products.

Keywords: Impurity, Pharmaceuticals, sources, detection, chromatography, spectroscopy, regulatory guidelines, control.