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Abstract

A REVIEW ON ANALYSIS OF IMPURITY PROFILING IN PHARMACEUTICALS

Akshay S. Shendge1*, Ramdas B. Darade1, Amol Gayke2, Vikram Sarukh2

1JES’s SND College of Pharmacy, Yeola, Nashik, Maharashtra, India
2JES’s SND College of Pharmacy, Yeola, Nashik, Maharashtra, India

ABSTRACT

This review provides a critical analysis of impurity profiling within the pharmaceutical domain, underscoring its pivotal function in the assurance of drug safety and therapeutic effectiveness. Impurities, constituted by any unintended components within pharmaceutical substances or products, are recognized as potentially arising from diverse phases of the drug lifecycle, encompassing synthetic processes, manufacturing procedures, and storage conditions. The identification and quantification of these impurities, through impurity profiling, are posited as indispensable for the preservation of product quality, compliance with regulatory frameworks (as defined by ICH guidelines), and the optimization of manufacturing paradigms. The imperative for impurity profiling is derived from its direct influence on the safety, efficacy, quality, and stability attributes of pharmaceutical products. A comprehensive discussion of organic, inorganic, and residual solvent impurities is presented, elucidating their respective origins and formation mechanisms. Analytical methodologies, including chromatographic techniques such as high-performance liquid chromatography (HPLC), gas chromatography (GC), and thin-layer chromatography (TLC), alongsidespectroscopic technique such as mass spectrometry (MS), nuclear magnetic resonance (NMR), infrared spectroscopy (IR), and ultraviolet-visible spectroscopy (UV-Vis), are emphasized for their efficacy in the detection and characterization of impurities. Moreover, the review accentuates the significance of impurity control through the implementation of robust process development, rigorous analytical monitoring, and adherence to established specifications, thereby ensuring patient safety and the reliability of pharmaceutical products.

Keywords: Mycobacterium tuberculosis, anti-mycobacterial activity, mechanisms, resistance, synthetic methods, SARs


[Full Text Article]