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@article{176552,
        author = {Sneha Arun Lahamge and Ravindra Chandrakant Lawande and Pranay Laxman Lokhande and Akash Bhagwan Maharnor and Kajal Sampat Marathe and Someshwar Mankar},
        title = {REVIEW ON :ADVANCED TECHNIQUES FOR DETECTING AND CONTROLLING GENOTOXIC IMPURITIES},
        journal = {International Journal of Innovative Research in Technology},
        year = {2025},
        volume = {11},
        number = {11},
        pages = {5830-5834},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=176552},
        abstract = {Genotoxic impurities (GIs) are known to be carcinogenic, making their management during the synthesis of pharmaceuticals crucial for ensuring the safe use of drugs, even at trace levels. The existence of DNA-reactive impurities in drug substances and products presents a considerable challenge for both drug regulators and the pharmaceutical industry. Numerous regulatory guidelines and position papers have been established to regulate the permissible levels of these impurities. This compilation provides updated information on GIs and reviews the regulatory considerations associated with them in active pharmaceutical ingredients and drug formulations. It also includes a thorough discussion of control strategies related to GIs. Analyzing GIs is a complex and demanding aspect of the drug development process, with the detection and quantification of these impurities at parts per million (ppm) or parts per billion (ppb) levels posing significant challenges for analysts. Consequently, various approaches for the analysis of GIs are also examined.},
        keywords = {Genotoxic impurities, Genotoxicity, Sources, Guidelines, Techniques for quantification},
        month = {April},
        }