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@article{162022,
        author = {Rutuja Mali and Mayuri Patil and Priti Patil and Anuradha Savairam and Pritam Salokhe and Nilesh Chougule},
        title = {Recent advance study of profiling and control of impurities in API},
        journal = {International Journal of Innovative Research in Technology},
        year = {},
        volume = {10},
        number = {7},
        pages = {257-265},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=162022},
        abstract = {The review gives brief introduction about process and product related impurities and
emphasizes on the development of novel analytical methods for their determination. It describes application of modern analytical techniques, particularly the UPLC, LC-MS, HRMS, GC-MS and HPTLC. In addition to that the application of nuclear magnetic resonance (NMR) spectroscopy was also discussed for characterization of impurities and degradation products. The significance of quality, efficacy and safety of drug substance/products including the source of impurities, kinds of impurities; adverse effects by the presence of impurities, quality control of impurities, necessity for development of impurity profiling methods, identification of impurities and regulatory aspects were discussed.  Other important aspects that were described forced degradation studies and development of stability indicating assay methods.
},
        keywords = {Analytical Method, Regulatory Guidelines },
        month = {},
        }