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Now days it becomes major challenge to find out impurities and remove them which is present in our preparations. So, Impurity profile has become necessary according to various regulatory authorities i.e. International Conference on Harmonization (ICH) as well as the United States Food and Drug administration (FDA) are contributing on the identification of impurities in Active Pharmaceutical Ingredients (APIs) and maintaining their purity for better results. Impurity profiling is the common name of a group of analytical activities such as description, quantitation & characterization of the identified and unidentified impurities present in new drug substances. So generally it includes stages of detection of various impurities, identification of different impurities and quantitative determination of organic, inorganic impurities, as well as residual solvents in bulk drugs and pharmaceutical formulations. Since this is the best way to characterize the Quality, Purity, Stability and stability of bulk drugs and pharmaceutical formulations and this becomes the core activity in modern drug analysis.
Keywords:
Impurity profiling; Classification; Sources of impurities; Analytical method development and validation for impurity profile; Current marketed formulation which contain impurity.
Cite Article:
"RECENT APPROACHES FOR IMPURITY PROFILING: A REVIEW", International Journal for Research Trends and Innovation (www.ijrti.org), ISSN:2455-2631, Vol.5, Issue 5, page no.111 - 115, May-2020, Available :http://www.ijrti.org/papers/IJRTI2005018.pdf
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ISSN:
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator