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@article{191729,
        author = {Rajeshwari V. Dugdhe and Kanchan J. Jagtap and Avinash B. Darekar},
        title = {Active Pharmaceutical Ingredients (APIs) and Their Impurity Profiling in Pharmaceutical Analysis},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {8},
        pages = {7472-7480},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=191729},
        abstract = {Impurity The term impurity is not liked by pharmaceutical and industry personnel, as quality is a priority for them. Here we discuss various impurities that may be present in API preparations. This review article describes various terminologies, regulatory guidelines, and basic techniques, e.g. HPLC, LC-MS, TLC, aimed to help the newcomer understand and identify impurities and quantify them quantitatively with the added advantage of profiling as well. This paper stresses mainly the identification and control of various impurities, namely organic, inorganic, and genotoxic. For all materials, the ultimate goal is quality. Impurities can affect quality; therefore, knowing the type of impurities will help them in formulating quality products. USFDA, ICH, and other regulatory bodies have increased their attention on the identification of impurities in pharmaceutical active ingredients and the purity requirements that must be met.The process of collecting and evaluating data to determine the biological safety of an individual impurity, and thus its qualification level, provides the need and necessity of profiling in the study of medicines. Profiling of impurities involves the detection, identification, quantitation, and characterization of these undesirable chemical substances to meet regulatory requirements and ensure patients' safety. The quality, purity, and safety of APIs need to be guaranteed in pharmaceutical analysis, since impurities may result from synthesis routes, starting materials, deterioration, or storage environments. Generally speaking, the comprehensive evaluation of impurities is indispensable in the generation of safe, effective, high-quality pharmaceutical products.},
        keywords = {Active Medicinal Component (AMC), Impurity analysis, Drug analysis, Natural contaminants, Chemical contaminants, Residual solvents LC-MS, Spectrophotometric techniques, Chromatographic methods.},
        month = {January},
        }