JOURNAL OF CHILEAN CHEMICAL SOCIETY

Vol 62 No 2 (2017): Journal of the Chilean Chemical Society
Original Research Papers

REVIEW ARTICLE IMPURITY PROFILING OF DRUGS TOWARDS SAFETY AND EFFICACY: THEORY AND PRACTICE

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  • Kiran R. Dhangar,
  • Rakesh B. Jagtap,
  • Sanjay J. Surana,
  • Atul A. Shirkhedkar
Kiran R. Dhangar
Department of Pharmaceutical Chemistry, R.C. Patel Institute of Pharmaceutical Education and Research
Rakesh B. Jagtap
Department of Pharmaceutical Chemistry, R.C. Patel Institute of Pharmaceutical Education and Research
Sanjay J. Surana
Department of Pharmaceutical Chemistry, R.C. Patel Institute of Pharmaceutical Education and Research
Atul A. Shirkhedkar
Department of Pharmaceutical Chemistry, R.C. Patel Institute of Pharmaceutical Education and Research
Published June 16, 2017
Keywords
  • Impurity Profiling,
  • Regulatory guidelines,
  • Residual solvent,
  • Genotoxicity
How to Cite
Dhangar, K. R., Jagtap, R. B., Surana, S. J., & Shirkhedkar, A. A. (2017). REVIEW ARTICLE IMPURITY PROFILING OF DRUGS TOWARDS SAFETY AND EFFICACY: THEORY AND PRACTICE. Journal of the Chilean Chemical Society, 62(2). Retrieved from https://jcchems.com/index.php/JCCHEMS/article/view/204

Copyright (c) 2017 Kiran R. Dhangar, Rakesh B. Jagtap, Sanjay J. Surana, Atul A. Shirkhedkar

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Abstract

Last decade has witnessed enormous changes in the studies of impurity profiling of drugs which can be reflected from pharmacopoeia and regulatory guidelines. The present review article is an attempt to provide comprehensive knowledge about various aspects and details about the impurity profiling in context with regulatory guidelines. Article also focused on isolation, separation and characterization techniques of impurities. It gives preliminary idea about applicability of virtual software used for studies on safety limit for impurities. The comprehensive information related to residual solvents, residual metals and genotoxicity studies of isolated impurities have also been incorporated into present article.

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