Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

@article{189488,
        author = {Pyla. Sivalalitha},
        title = {Impurity Profiling in Active Pharmaceutical Ingredients: Techniques, Regulations, and Applications},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {8},
        pages = {87-90},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=189488},
        abstract = {Impurity profiling encompasses the analytical methodology applied for the detection, identification, characterization, and quantification of organic and inorganic impurities and residual solvents present in bulk drugs and pharmaceutical formulations. It is extremely useful in the quality and stability assessment of the product, apart from fulfilling regulatory expectations. Each change in the synthesis, formulation, or manufacturing step can result in the introduction of new impurities. Therefore, monitoring needs to be done continuously. The FDA, CDHA, and ICH are some of the agencies that give great importance to the tight control of impurities in APIs. These may be due to raw materials, catalysts, processing aids, or products of degradation such as hydrolysis, oxidation, and photolysis, including enantiomeric impurities.
This is reflected in the increasing number of pharmacopoeias, including the Indian, American, and British Pharmacopoeias, which all presently define limits for acceptable impurity levels. HPLC, GC, CE, MS, NMR, IR, UV spectroscopy, and Raman spectroscopy are some of the analytical tools employed in impurity characterization. LC–MS, GC–MS, and LC–NMR are some of the hyphenated techniques that are widely employed because of their enhanced sensitivity and structural elucidation capabilities. Thus, impurity profiling assumes an important role in the safety, efficacy, and quality of pharmaceutical products.},
        keywords = {Impurity Profiling; Enantiomeric Impurities; Pharmaceutical Quality.},
        month = {January},
        }