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Review Papers | Pharmaceutical Science | India | Volume 12 Issue 8, August 2023 | Rating: 5.1 / 10

Comprehensive Overview of Impurity Profiling in Pharmaceutical Products: Regulations, Characterization, and Analytical Techniques

Bommana Sahithi ^[2] | Dr. M. Sunitha Reddy ^[2]

Abstract: This article provides a thorough exploration of the critical role of impurity profiling in the pharmaceutical industry. Impurities, unwanted chemical substances present alongside active pharmaceutical ingredients APIs, can compromise the safety and efficacy of drugs. Various regulatory bodies, including ICH, FDA, and CDHA, have established stringent purity requirements to ensure the identification and control of impurities in both formulated products and APIs. The classification of impurities into organic, inorganic, and residual solvents is outlined, and their permissible limits are emphasized. The concept of impurity profiling, encompassing identification, structural elucidation, and quantitative determination, is elucidated, underscoring its significance in drug design, quality assurance, and safety assessment. The article also delves into separation techniques such as Accelerated Solvent Extraction and Gas Chromatography, as well as spectroscopy methods like NMR, mass spectrometry, and hyphenated techniques including LC - MS and LC - NMR. This comprehensive overview underscores the pivotal role of impurity profiling in ensuring pharmaceutical product quality and patient safety.

Keywords: Impurities, impurity profiling, pharmaceutical products, regulatory authorities, analytical techniques

Edition: Volume 12 Issue 8, August 2023,

Pages: 1875 - 1881